News

EU Pharmacovigilance Risk Assessment Committee clears Diane 35 (Bayer) for Acne

During its meeting of 13 to 16 May 2013, the EMA Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the benefits of Diane 35 (Bayer HealthCare) and other medicines containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms continue to outweigh their risks for the treatment of moderate to severe Acne related to androgen sensitivity and/or hirsutism (excessive unwanted growth ...

Teva Pharmaceutical Industries will market Adasuve for treatment of agitation in Schizophrenia in the United States

Alexza Pharmaceuticals, Inc. announced that they have entered into an exclusive U.S. license and supply agreement with Teva Pharmaceutical Industries Ltd for Adasuve (Staccato loxapine).

Adasuve is Alexza's first approved product and was approved by the FDA in December 2012 and by the European Medicines Agency in February 2013. Teva Pharmaceutical USA Inc. is Alexza's commercial partner for Adasuve ...

Phase IIb study with STX 209 (Seaside Therapeutics) reports on efficacy in Autism Spectrum Disorder

Study 209AS208 is a randomized, double-blind, placebo-controlled Phase IIb study which , evaluated the safety, tolerability, and efficacy of STX 209 ( arbaclofen) from Seaside Therapeutics, in 150 subjects (age 5 to 21 years) with Autism Spectrum Disorder (ASD), with a particular focus on the core impairments of social function.

Patients were randomized to receive either arbaclofen or placebo ...

FDA approves Vyvanse (Shire) as maintenance treatment of ADHD for children and adolescents

The FDA has on 1 May 2013, approved the prescription medication Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) from Shire ,as a maintenance treatment in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Vyvanse is currently approved as a maintenance treatment in adults with ADHD. With this new approval, Vyvanse becomes the only stimulant approved for maintenance treatment in children, adolescents, and ...

FDA Advisory Committee recommends Probuphine to treat Opiod Dependence

Titan Pharmaceuticals, Inc. has announced that the majority of Psychopharmacologic Drugs Advisory Committee (PDAC) of the FDA members recognized the favorable benefit-risk profile of Probuphine and voted for approval (10 positive votes, 4 negative votes and 1 abstention) in favour of approval.

Probuphine is a long-acting, subdermal implant formulation of buprenorphine for the maintenance treatment of adult patients ...

Vanda Pharmaceuticals withdraws EU MMA for Fanaptum to treat Schizophrenia

Vanda Pharmaceuticals has withdrawn its Marketing Authorization Application (MAA) submitted to the EMA's Committee for Medicinal Products for Human Use (CHMP) for Fanaptum (oral iloperidone tablets) for the treatment of adult patients with Schizophrenia. This withdrawal is based on a request by the CHMP/Rapporteur/Co-rapporteur for Vanda to submit the results from an ongoing relapse prevention, randomized iloperidone-placebo withdrawal study in ...

Lundbeck and Otsuka expand collaboration relating to Abilify

Lundbeck and Otsuka now expand their existing collaboration to include promotion of Abilify (aripiprazole) in 14 European countries starting April 1, 2013. Under the agreement, Otsuka and Lundbeck will jointly promote Abilify in Denmark, Finland, Germany, Italy, Spain, Sweden and the United Kingdom. Lundbeck will promote Abilify in Austria, Belgium, Ireland, Netherlands, Poland, Portugal and Romania. The agreement provides ...

FDA approves Abilify Maintena as a treatment for Schizophrenia

H. Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. have announced that the FDA has on 28 February 2013 approved Abilify Maintena (aripiprazole) for extended release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of Schizophrenia.

Abilify Maintena is the first dopamine D2 partial agonist approved as a once-monthly injection. It contributes a new treatment option to ...

EU approves Selincro (Biotie/Lundbeck) for treatment of Alcohol Dependence

Biotie has announced that its partner H.Lundbeck A/S (Lundbeck) has received European marketing authorization from the European Commission for Selincro (nalmefene; an opioid system modulator) for the reduction of alcohol consumption in adult patients with Alcohol Dependence. The marketing authorization applies to all 27 European Union member states.

Selincro is a unique dual-acting opioid system modulator and acts on ...

Adasuve ( Alexza/Ferrer) is EU approved to control agitation in Schizophrenia patients

Alexza Pharmaceuticals, Inc.and Grupo Ferrer Internacional, S.A.,announced that the European Commission has granted marketing authorization for Adasuve (Staccato loxapine). In the European Union (EU), Adasuve 4.5 mg and 9.1 mg inhalation powder loxapine, pre-dispensed, is authorized for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder

The Adasuve marketing authorization requires that patients receive ...

Tasimelteon (Vanda) fails trial for treatment of Depression.

Vanda Pharmaceuticals Inc. has announced top-line results of the Phase IIb/III clinical study (MAGELLAN) in Major Depressive Disorder (MDD), investigating the efficacy and safety of tasimelteon as a monotherapy in the treatment of patients with MDD. The clinical study did not meet the primary endpoint of change from baseline in the Hamilton Depression Scale (HAMD-17) after 8 weeks of treatment ...

Abilify Depot is filed in EU for maintenance therapy of Schizophrenia

The European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for a once-monthly intramuscular depot formulation of Abilify (aripiprazole) from Otsuka Pharma and Lundbeck. The companies are seeking approval of the long-acting formulation of the dopamine D2 partial agonist as a maintenance therapy for adults with Schizophrenia....

Tasimelteon (Vanda)success in Phase III study in Non 24 Hour Disorder

Vanda Pharmaceuticals has announced positive results from the SET (Safety and Efficacy of Tasimelteon) Phase III study, evaluating tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24). Tasimelteon succeeded in the primary endpoint of Entrainment of the melatonin (aMT6s) rhythm as compared to placebo. Additionally, tasimelteon demonstrated significant improvements across a number of sleep and wake parameters including ...

Positive European regulatory procedure for Elvanse (Shire) for ADHD

Shire plc announced a positive outcome from the European Decentralised Procedure (DCP) for Elvanse (to be known as Tyvense in Ireland). Elvanse is indicated as part of a comprehensive treatment programme for Attention Deficit/Hyperactivity Disorder (ADHD) in children aged 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate. The MHRA of the UK, ...

CHMP rejects Fanaptum (Vanda Pharma)for treatment of Schizophrenia

Vanda Pharmaceuticals Inc. has announced that the European Medicines Agency's Committee for Medicinal Product for Human Use (CHMP) has issued a negative opinion recommending against approval of Fanaptum (oral iloperidone tablets) for the treatment of Schizophrenia in adult patients in the European Union. The CHMP was of the opinion that the benefits of Fanaptum did not outweigh its risks and ...

CHMP recommends Selincro (Biotie/Lundbeck) for treatment of Alcholol Dependence

Biotie announced that its partner H.Lundbeck A/S (Lundbeck) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending marketing authorization of Selincro (nalmefene; an opioid system modulator) for the reduction of alcohol consumption in adult patients with Alcohol Dependence who have a high level of alcohol consumption. Once approved, ...

CHMP recommends Adusive (Alexza/Ferrer)for control of agitation in Schizophrenia and Bipolar patients

Alexza Pharmaceuticals, Inc. and Grupo Ferrer Internacional, S.A., have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending that Adasuve (Staccato loxapine) be granted European Union centralized marketing authorization. The CHMP recommends that Adasuve be authorized in the EU for the rapid control of mild-to-moderate agitation in adult ...

Phase II trial of GLYX 13 (Naurex) shows positive results in patients with Depression

Phase IIa results show that a single administration of anti-depressant GLYX 13, from Naurex, produced statistically significant reductions in Depression scores in subjects who had failed treatment with one or more antidepressant agents. The reductions were evident within 24 hours and persisted for an average of seven days. Importantly, the effect size, a measure of the magnitude of the drug's ...

Forest files cariprazine at FDA for Schizophrenia and Bipolar Disorder

Forest Laboratories, Inc., and Gedeon Richter Plc. announced that Forest has submitted a New Drug Application (NDA) to the FDA for cariprazine, a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors. Cariprazine was discovered by Gedeon Richter Plc and is licensed to Forest Laboratories Inc., in the U.S. and Canada. The application for the treatment of ...

Seroquel XR (AstraZeneca) is declared invalid by German Federal Court

The Federal Patent Court in Germany has found the formulation patent protecting Seroquel XR (quetiapine fumarate) prolonged-release tablets – marketed as Seroquel Prolong in Germany by Astra Zeneca – to be invalid. The patent was challenged by Accord Healthcare .Total sales of Seroquel XR in Germany for the ten months ended 31 October 2012 were $82 million....

Suvorexant is filed at FDA by Merck Inc., for Sleep Disorder

A New Drug Application (NDA) for suvorexant, an investigational insomnia medicine, from Merck Inc., has been accepted for standard review by the FDA. Suvorexant will be evaluated by the Controlled Substance Staff of the FDA during NDA review. If approved by the FDA, suvorexant will become available after a schedule assessment and determination has been completed by the U.S. Drug ...

Analysis suggests Neurostar TMS therapy (Neuronetics) has fewer side effects than drugs in treating Depression

A new analysis shows that magnetic stimulation of the brain using the Neurostar Transcranial Magnetic Stimulation system, from Neuronetics, can reduce symptoms of Depression yet causes little disruption to sleep or arousal behaviour, in contrast to conventional drugs. Researchers carried out a secondary analysis of 301 patients at 23 sites to compare responses to transcranial magnetic stimulation therapy and placebo ...

Lurasidone (Takeda) filed at EMA for Schizophrenia

The European Medicines Agency (EMA) has accepted for review the marketing authorisation application (MAA) from Takeda for the oral atypical antipsychotic, lurasidone hydrochloride, for the treatment of Schizophrenia. This drug was developed by Dainippon Sumitomo and licensed to Takeda in March 2011, granting the latter exclusive commercialisation rights for lurasidone in 26 EU member states (excluding the UK), and Switzerland, ...

Chantix/Champix (Pfizer) Smoking Cessation study in depressed patients

Pfizer announced the completion of a double-blind, placebo-controlled, randomized clinical trial designed to assess the efficacy and safety of Chantix/Champix (varenicline) 1 mg BID in comparison to placebo for Smoking Cessation in patients with a past or present diagnosis of Major Depressive Disorder (MDD). The study met its primary and secondary efficacy endpoints. Subjects in the varenicline group had ...

Novartis to discontinue development of long acting Fanapt for Schizophrenia

Novartis Pharma AG is discontinuing development of a long-acting injectable version of Fanapt (iloperidone) reported Vanda Pharmaceuticals in a securities filing. Novartis has marketed Fanapt, which is Vanda’s lead product, since 2010. Novartis has exclusive rights to develop and commercialize other formulations of Fanapt in the USA and Canada....

FDA approves Quillivant XR (Next Wave) for ADHD

The FDA has approved Quillivant XR (methylphenidate hydrochloride) from Next Wave Pharma for extended-release oral suspension for treatment of Attention Deficit Hyperactivity Disorder (ADHD). Quillivant XR is the first once-daily, extended-release liquid methylphenidate available for patients with ADHD.The drug will be launched early in 2013....

Levomilnacipran (Forest Labs/Pierre Fabre) filed at FDA for Major Depressive Disorder

Forest Laboratories, Inc. and Pierre Fabre Laboratories announced that Forest has submitted a New Drug Application (NDA) to the FDA for levomilnacipran, a serotonin norepinephrine reuptake inhibitor for the treatment of Major Depressive Disorder (MDD) in adults. Levomilnacipran was discovered by Pierre Fabre and jointly developed by Forest Laboratories and Pierre Fabre, under a licensing agreement in the U.S. and ...

Lundbeck files vortioxetine at EMA for Major Depressive Episodes

Lundbeck A/S has announced the submission to the European Medicines Agency (EMA) of a marketing authorisation application (MAA) for the approval of the investigational multimodal antidepressant vortioxetine (Lu AA21004), and the dossier has been accepted for review. Vortioxetine belongs to a new generation of antidepressants that has been developed for the treatment of patients with major depressive episodes (MDE).The data ...

Lundbeck files vortioxetine at EMA for Major Depressive Episodes

Lundbeck A/S has announced the submission to the European Medicines Agency (EMA) of a marketing authorisation application (MAA) for the approval of the investigational multimodal antidepressant vortioxetine (Lu AA21004), and the dossier has been accepted for review. Vortioxetine belongs to a new generation of antidepressants that has been developed for the treatment of patients with major depressive episodes (MDE).The data ...

TC 5619 (Targacept) fails Phase II trial in ADHDi

Targacept Inc., has announced top-line results from a Phase II trial of TC-5619 as a treatment for inattentive-predominant attention deficit/hyperactivity disorder (ADHDi). In the trial, TC-5619 did not meet the primary outcome measure, change from baseline on the inattention subscale of the Conners' Adult ADHD Rating Scale-Investigator-Rated (CAARS-INV), after four weeks of treatment versus placebo. Across the study measures, patients ...

Positive results from pivotal study of BEMA Buprenorphine/Naloxone (Biodelivery Sciences) for Opioid Dependence

A pivotal pharmacokinetic study BNX-103 for BEMA Buprenorphine/Naloxone from Biodelivery Sciences Inc, has provided positive results in treatment of Opioid Dependence. The drug utilizes the patented BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine combined with the opioid antagonist naloxone. The goals of the study were to demonstrate that two key pharmacokinetic parameters, maximum drug plasma concentration (Cmax) and total drug ...

Orexo files Zubsolv at FDA for treatment of Opioid Dependence

Orexo files at FDA for Zubsolv (buprenorphine and naloxone) for the treatment of Opioid Dependence. The earlier submission is expected to be of major commercial importance, as it provides a potential launch of Zubsolv in the third quarter of 2013 – ahead of other branded competitors. In clinical studies Zubsolv has demonstrated an accelerated dissolve time, has a smaller tablet ...

Lundbeck/Otsuka re-file Abilify Depot with the FDA as a treatment for Schizophrenia

Lundbeck and Otsuka Pharmaceutical Co., Ltd. announced that the FDA has accepted for review the resubmission of the New Drug Application (NDA) for aripiprazole depot formulation, a potential treatment for schizophrenia. FDA stated that this resubmission constituted a complete class 2 response to their action letter of July 26, 2012. The Prescription Drug User Fee Act (PDUFA) goal date is ...

FDA reviews sNDA of Vyvanse (Shire) as maintenenace treatment for young patients with ADHD

The FDA has accepted the filing for review of a supplemental New Drug Application (sNDA) for Vyvanse (lisdexamfetamine dimesylate) Capsules, from Shire, as a maintenance treatment in children and adolescents ages 6 to 17 years with Attention-Deficit/Hyperactivity Disorder (ADHD). This application is based on results of a Phase IIIb, randomized withdrawal, multicenter, extension study to evaluate the long-term maintenance of ...

Pomaglumetad methionil (Eli Lilly) fails Phase II studies in Schizophrenia

Eli Lilly has announced the decision to stop ongoing clinical studies investigating pomaglumetad methionil, also known as mGlu2/3, for the treatment of patients suffering from Schizophrenia. The decision was made after a recently conducted independent futility analysis concluded HBBN, the second of Lilly's two pivotal studies, was unlikely to be positive in its primary efficacy endpoint if enrolled to completion. ...

FDA approve new dosage of Suboxone (Reckitt Benckiser) for treating Opioid Dependence

The FDA has approved 4 mg and 12 mg doses of Suboxone (buprenorphine and naloxone) sublingual film, from Reckitt Benckiser, for maintenance treatment of Opioid Dependence, also known as prescription opioid painkiller and heroin addiction. Reckitt Benckiser developed these strengths in an effort to help mitigate the risk of unintentional multi-dose pediatric exposure, which is a major public health concern ...

FDA issues Complete Response Letter relating to Abilify Depot (Otsuka/Lundbeck) for monthly treatment of Schizophrenia

Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. have announced receipt of a Complete Response Letter from the FDA to the New Drug Application (NDA) for the investigational intramuscular (IM) depot formulation of Abilify (aripiprazole). In the letter, the only issue FDA cited was deficiencies from a recent inspection of a third-party supplier of sterile water....

Lyrica (Pfizer) success in GAD discontinuation symptoms

Pfizer announced top-line results for Lyrica (pregabalin) capsules Study A0081147 – Long Term Safety and Efficacy of Pregabalin in Subjects with Generalized Anxiety Disorder (GAD) –which demonstrate that drug discontinuation symptoms were low after tapering Lyrica treatment following three months and six months in GAD patients. The European Medicines Agency (EMA) requested this study to investigate the relationship between dose ...

MK 4305 (Merck Inc.) data from two Phase III trials for Sleep Disorder

Merck announced detailed data from the two Phase III pivotal trials of MK 4305 (suvorexant) at the SLEEP 2012 annual meeting of the Associated Professional Sleep Societies.In both trials, on all primary subjective measures, patients who took suvorexant fell asleep significantly faster and stayed asleep longer compared to patients taking placebo at one month and three months (p<0.003). On the ...

Vanda Pharma announces Non-24 Hour Sleep Disorder

Vanda Pharma announced at the SLEEP conference of the Associated Professional Sleep Societies that 70% of totally blind people with sleep complaints suffer from Non-24 Hour Disorder, a circadian rhythm disorder characterised by a chronically misaligned body clock. In a poster presented at the conference " Seventy per cent of totally blind people with sleep complaints are not entrained to ...

Relday from Zogenix is filed at FDA for Schizophrenia

Zogenix has submitted an investigational new drug application to the FDA for Relday, which is a combination of Zogenix's DosePro needle-free, subcutaneous drug delivery system plus a proprietary, subcutaneous once-monthly formulation of risperidone for treating Schizophrenia.If approved, Relday will be the first subcutaneous, needle-free antipsychotic product that allows for once-monthly dosing. Zogenix believes that Relday will offer an improved pharmacokinetic ...

FDA approves Absorica (Ranbaxy) for severe Acne

FDA has approved Absorica on 25 May 2012, a patented formulation of isotretinoin, as a treatment for severe recalcitrant nodular acne. Ranbaxy is expected to launch Absorica in the USA in the fourth-quarter 2012....

Phase III trials shows Vyvanse (Shire) effective in children and adolescents with ADHD

Results from a Phase III extension study of Vyvanse (lisdexamfetamine dimesylate), from Shire, show that after 6 months of treatment, a significantly lower proportion of subjects with ADHD experience treatment failure compared to those on placebo. This study was designed to evaluate the long-term efficacy and safety of Vyvanse for the treatment of ADHD in children and adolescents aged 6 ...

Lu AA 21004 successful Phase III trials in Depression

Lundbeck announced positive top-line results from three recently completed phase III clinical studies of Lu AA21004, an investigational drug for the treatment of adults with major depressive disorder (MDD) using dosages from 10 to 20mg. The positive results from these three studies showed that Lu AA21004 statistically significantly reduced depression symptoms in patients with MDD compared to placebo as measured ...

FDA approves Fabior (Allergan) for Acne vulgaris in 12 year olds and upwards

The FDA has approved the New Drug Application for Fabior (tazarotene) Foam, 0.1%, from Allergan, for the treatment of Acne vulgaris in patients 12 years of age and older. It is the only retinoid in a topical foam formulation approved for this indication in the US. The approval of tazarotene foam was based on two multi-centre, randomized, double-blind, vehicle-controlled pivotal ...

Abilify Depot(Otsuka) maintenance of Schizophrenia study comfirmed

A Phase III study of once-monthly Abilify (aripiprazole intramuscular depot formulation) from Otsuka/Lundbeck for the maintenance treatment of Schizophrenia, showed that the product was effective in delaying time to relapse for Schizophrenia patients. The results reported this week represent the final data analysis of the study by Otsuka, which was terminated early after 50% of the 125 events needed to ...

Neurostar TMS therapy (Neuronetics) success in Depression

Patients with unipolar, non-psychotic Major Depressive Disorder (MDD) receiving NeuroStar TMS Therapy from Neuronetics achieved significant improvements in both depression symptoms and in quality of life measurements. Overall, 58 percent of patients achieved a positive response to NeuroStar TMS therapy, with 37 percent of patients achieving remission from their depression. After an average of five weeks of NeuroStar treatment, the ...

FDA approves expanded dose range for Latuda (Sunovion Pharma) in treatment of adult Schizophrenia

The FDA has approved an expanded dose range for Latuda (lurasidone), from Sunovion Pharma, for treatment of adults with Schizophrenia. The new recommended dose range (40-160 mg/day) includes approval of 120 mg/day and 160 mg/day doses plus a new 120 mg tablet. This expanded range is based on results from five studies evaluating the safety and efficacy of Latuda, in ...

Cardiovascular safety concerns over smoking cessation drug Chantix (Pfizer) misleading

A new analysis of Chantix (varenicline), from Pfizer, found no clinically or statistically significant increase in serious adverse cardiovascular events. The findings from 22 trials with more than 9,200 participants indicate a difference in risk of only 0.27 percent between those on varenicline versus placebo, or about a quarter of one percent. It included 22 double-blind, randomized controlled trials with ...

FDA issues Complete Response Letter to Alexza Pharma for Adasuve

Alexza Pharmaceuticals announced that it has received a Complete Response Letter(CRL) from the FDA regarding its New Drug Application (NDA) for ADASUVE (loxapine) inhalation powder, 5 mg and 10 mg. The CRL was issued by FDA's Center for Drug Evaluation and Research indicating that the NDA review cycle is complete and the application is not ready for approval in its ...

Phase II study of Vyvanse (Shire) for Binge Eating Disorder

A study to evaluate the safety and efficacy of Vyvanse(lisdexamfetamine dimesylate) Capsules 30, 50 or 70 mg compared to placebo in adults with Binge Eating Disorder at Week 11 as measured by the number of binge days per week as assessed by clinical interview based on patient diary. A binge day was defined as a day during which at least ...

US court rules that Seroquel XR patent (AstraZeneca) is valid

A US court has ruled that the formulation patent for the extended-release version of the antipsychotic Seroquel XR is valid and has been been infringed by generics companies. The district court in New Jersey has found the formulation patent protecting Seroquel XR (quetiapine fumarate) extended-release tablets to be valid and ruled that four firms - Anchen Pharmaceuticals, Osmotica Pharmaceutical Corp, ...

Dr Reddy has FDA approval for generic Seroquel.

The US patent covering instant-release Seroquel (quetiapine) from AstraZeneca expired on March 26 .Dr Reddy Laboratories announces that the FDA has approved an Abbreviated New Drug Application for its 25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg versions. Sun Pharmaceutical Industries and Lupin have also received FDA approval to launch their generics in the US ...

Teva Pharma launches generic Seroquel and Seroquel XL

Teva Pharma UK has launched generic versions of Seroquel and Seroquel XL as Quetiapine and Quetiapine XL.Other generic versions are likely from Accord Pharma, Intas Pharma, Hexal and Sandoz. A 25 mg coated tablet of Seroquel costs $40.50 compared to $6.08 for the generic....

UK court rules AstraZeneca's patent on Seroquel XR is invalid

The UK High Court has ruled that AstraZeneca's patent on the extended-release version of Seroquel XR (quetiapine fumarate) is invalid. The patent had been challenged by Accord Healthcare, Intas Pharmaceuticals, Novartis' Hexal and Sandoz generics units and Teva. The UK ruling is the first that says the patent is invalid, in contrast to the decision in March by the District ...

AstraZeneca discontinues development of TC 5214 for Major Depreeive Disorder

AstraZeneca has ceased development of its nicotinic channel blocker TC 5214 for which it had collaborated with Targacept as an adjunctive treatment in depression patients who did not respond to initial treatment. In RENAISSANCE 4 and 5 trials TC 5214 did not meet its primary endpoint....

Successful Phase III trial for levomilnacipran ( Pierre Fabre/Forest Labs) in Major Depressive Disorder

Positive top-line results in a Phase III trial showed that treatment with levomilnacipran (F 2695) from Pierre Fabre/Forest Labs. significantly reduced depression symptoms in patients with Major Depressive Disorder compared to placebo, as early as week one.This is the second, positive Phase III study in this population and results from an additional late-stage fixed-dose study are expected in the spring. ...

Results of Study 102 for Quad (Gilead) for HIV

Phase III results were announced from the pivotal Study 102 demonstrating that Quad,from Gilead Sciences, a fixed-dose, single-tablet regimen made up of the investigational drugs elvitegravir and cobicistat combined with the two active ingredients in Truvada (emtricitabine and tenofovir), is non-inferior to Atripla (efavirenz/tenofovir/emtricitabine) after 48 weeks of therapy in treatment-naive adults. At the end of the trial, 88% of ...

Biotie/Lundbeck report results of Phase III studies for Selincro for Alcholol Dependence

Biotie announced that its partner H. Lundbeck A/S has presented results from the Phase III program of Selincro (nalmefene), an investigational compound for the treatment of Alcohol Dependence, at the 20th European Congress of Psychiatry (EPA) in Prague, Czech Republic. Data from the three placebo-controlled phase III studies (ESENSE 1, ESENSE 2 and SENSE) was discussed during the symposium. In ...

Phase III success in two studies for cariprazine (Forest/Richter) in Schizophrenia

Positive top-line results in 2 Phase III clinical trials of cariprazine (RGH-188), from Forest Labs and Gedeon Richter, were announced for the treatment of acute exacerbation of schizophrenia. For the primary endpoint in each study, the Positive And Negative Syndrome Scale (PANSS), the data showed that cariprazine-treated patients experienced significant symptom improvement compared to placebo-treated patients. All doses showed statistically ...

Sycrest(Lundbeck) is launched for Bipolar Disorder in UK

Sycrest (asenapine)from Lundbeck is launched in the UK for treatment of moderate to severe manic episodes associated with Bipolar Disorder in adults. EU approval was given in 2010. Sycrest is licensed by Lundbeck from Merck Inc. which markets the drug in the USA as Saphris for Schizophrenia and Bipolar Disorder. The advantages of the new antipsychotic are less weight gain ...

Sycrest(Lundbeck) is launched for Bipolar Disorder in UK

Sycrest(asenapine)from Lundbeck is launched in the UK for treatment of moderate to severe manic eposodes associated with Bipolar Disorder in adults. EU approval was given in 2010. Sycrest is licensed by Lundbeck from Merck Inc. which markets the drug in the USA as Saphris for Schizophrenia and Bipolar Disorder. The advantages of the new antipsychotic are a less weight gain ...

Intuniv (Shire) shows positive response for children with ADHD

A new trial has assessed the efficacy and safety of Intuniv (guanfacine extended release), from Shire, as an adjunct to psychostimulants in children and adolescents diagnosed with ADHD who had a suboptimal response to a psychostimulant alone. Participants continued their stable dose of psychostimulant given in the morning and were randomised to receive Intuniv in the morning, Intuniv in the ...

TC 5214 fails second Phase III trial for Major Depressive Disorder

AstraZeneca announced that the second RENAISSANCE Phase III study of TC-5214 for patients with Major Depressive Disorder did not meet its primary end point. The target measure was change in the Montgomery-Asberg Depression Rating Scale total score after eight weeks of treatment with TC-5214 as compared to placebo. TC-5214 was overall well tolerated in RENAISSANCE 2 and showed an adverse ...

FDA Advisory committee recommends Adasuve (Aexza Pharma)l for agitation with Sschizophrenia

The FDA Psychopharmacologic Advisory Committee voted 9-8 to recommend Adasuve (inhaled loxapine) from Alexza Pharma, to treat agitation associated with schizophrenia or bipolar disorder. There was no problem with efficacy and an attraction in having a fast acting medication for agitated patients compared to needle administration with Abilify, Zyprexa or Geodon. However there have been no direct comparison studies of ...

FDA approves Intermezzo (Transcept Pharmaceuticals) for use with middle-of-the-night Insomnia

The FDA has approved Intermezzo (zolpidem tartrate sublingual tablets), from Transcept Pharmaceuticals, for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep. This is the first time the FDA has approved a drug for this condition. Intermezzo should only be used when a person has at least four hours of bedtime remaining. It ...

Abilify Depot(Otsuka/Lundbeck) is filed at FDA for Schizophrenia

The FDA has accepted the application from Otsuka Pharma for Abilify Depot,the once a month version of aripiprazole and Otsuka plans a filing in the EU in 2013. The Abilify patent in the USA will expire in April 2013. Otsuka and Lundbeck have a world wide collaboration to co-develop and co-promote new psychiatric drugs, including Abilify Depot. The companies will ...

Suboxone (Reckitt Benckiser) effective in large-scale trial for Opioid Dependence

A new study has found individuals addicted to prescription Opioid painkillers are more likely to succeed in treatment with the aid of the medication Suboxone(buprenorphine plus naloxone), from Reckitt Benckiser. This clinical trial involved more than 600 outpatients dependent on prescription opioids and each received Suboxone in conjunction with Standard Medical Management, in which physicians evaluated treatment effectiveness and recommended ...

Vivitrol (Alkermes Inc) shows sustained efficacy in Opioid Dependence study

Results from a one-year extension of a six-month pivotal study showed sustained efficacy of Vivitrol (once a month naltrexone), from Alkermes Inc, as measured by the number of Opioid-free urine screens in patients who received Vivitrol in combination with psychosocial treatment. At the onset, 114 patients from the six-month pivotal trial continued into the open-label, 52-week extension. Of these, sixty-seven ...

TC 5214 fails first Phase III trial for Major Depressive Disorder

Phase III results of TC 5214, a nicotinic channel blocker from AstraZeneca/Targacept, were disappointing in the first study (RENAISSANCE 3) of four studies as an adjunct therapy to an antidepressant in patients with major depressive disorder who do not respond adequately to initial treatment. The study did not meet its primary endpoint of change on the commonly-used Montgomery-Asberg Depression Rating ...

Chantix (Pfizer) raises suicide risk and is unsuitable for treating first-line Nicotine Addiction

According to a study in the journal PLoS One, the poor safety profile of the Nicotine Addiction drug Chantix (varenicline), from Pfizer, makes it unsuitable for first-line use. The study reveals that Chantix, which already carries a "black box warning" from the FDA, showed a substantially increased risk of reported depression or suicidal behavior compared to other smoking-cessation treatments. It ...

FDA finds ADHD drugs have no link to Cardiovascular problems

The US FDA has announced that a large, recently-completed study in children and young adults treated with medication for Attention-Deficit/Hyperactivity Disorder (ADHD) has not shown an association between use of certain ADHD medications and adverse cardiovascular events. These adverse cardiovascular events include stroke, heart attack (myocardial infarction or MI), and sudden cardiac death. The study was conducted with 1,200,438 children ...

Novartis cancels development of Valdoxan in the USA

Novartis has cancelled development of agomelatine (AGO178) in major depressive disorder in the USA. The drug is known as Valdoxan in the rest of the world where it originated with and is marketed by Servier Laboratories which had ,in 2006, licensed the USA rights to Novartis....

Genes predict child's response to Equasym in treatment of ADHD

New research suggests that the genetic characteristics of a child with ADHD may offer a useful indicator in selecting the treatment most suitable for them. The study, published in the Journal of the American Academy of Child and Adolescent Psychiatry, found that out of 89 children aged from 7-11 with ADHD, those with specific variations of the dopamine receptor D4 ...

FDA approves generic Zyprexa to treat Schizophrenia and Bipolar Disorder

The FDA has approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tablets) to treat Schizophrenia and Bipolar Disorder. The agency points out that generic drugs approved by FDA have the same high quality, strength, purity, and stability as brand-name drugs, and their manufacturing, packaging, and testing sites must pass the same quality standards ...

Vyvanse positive in European Phase III study for ADHD

Vyvanse- lisdexamfetamine (LDX) from Shire is the long acting, prodrug of dexamfetamine for the treatment of ADHD and is currently licensed only in the US, Canada and Brazil. A study, conducted at 48 sites across Europe, showed that LDX demonstrated efficacy on the primary and key secondary measures compared to placebo, and a safety profile consistent with the known effects ...

Takeda discontinues Rozerem for Insomnia in the EU

Takeda discontinues the development of Rozerem (ramelteon)the MT1 and MT2 receptor agonist for Insomnia in the EU following the withdrawal of its application for approval after a negative opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP)....

Phase III data for cariprazine positive for acute mania associated with Bipolar 1 Disorder.

A five-week study of cariprazine ,a dopamine D3-preferring D3/D2 receptor partial agonist, from Forest Laboratories and Gedeon Richter, enrolled 312 adult patients with acute mania associated with bipolar 1 disorder meeting the DSM-IV-TR criteria who were randomised to receive at least one dose of cariprazine (3-12mg/day) for three weeks followed by a two week period of safety assessments. Its primary ...

Somaxon may head for OTC status in USA for Insomnia

Somaxon Pharmaceuticals is likely to seek regulatory approval in the USA for an over-the-counter version of Silenor (low dose doxepin). A recent meeting at the FDA seemed positive. The marketing of Silenor with Proctor & Gamble launched 12 months ago has not been successful due to low cost competition from generic versions of Ambien and Ambien CR (extended-release zolpidem).Somaxon plans ...

FDA to review re-submitted Intermezzo in November 2011 for Insomnia

Transcept Pharma had resubmitted its drug application for its middle-of-the-night insomnia drug Intermezzo (zolpidem tartrate sublingual tablet) in January 2011. The drug had failed to win approval in October 2009. The FDA sent out a Complete Response Letter regarding the resubmitted New Drug Application. In it, the FDA stated that it cannot conclude that Intermezzo can be used safely based ...

FDA supply Complete Response Letter for Intermezzo

The FDA has sent out a Complete Response Letter to Transcept Pharma regarding its resubmitted New Drug Application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet) for Sleeping Disorders. In its Complete Response Letter, the FDA confirmed that the company has adequately demonstrated that Intermezzo is efficacious for use in treating insomnia when a middle-of-the-night awakening is followed by difficulty returning ...

Sycrest approved in EU for bipolar 1 disorder and FDA extends indications

EMA has approved the Marketing Authorization Application for Sycrest (asenapine) sublingual tablets from Merck Inc./MSD for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The drug is not EU approved for schizophrenia but has both approvals in USA. Sycrest is known as Saphris in the USA. Merck announced on 11/9/2010 that the FDA ...