News
Advert for Healthcare Professionals only
Sleep Medicine
FDA approves Vyvanse (Shire) as maintenance treatment of ADHD for children and adolescents
03-May-2013The 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 ...
Tasimelteon (Vanda) fails trial for treatment of Depression.
01-Feb-2013Vanda 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 ...
Tasimelteon (Vanda)success in Phase III study in Non 24 Hour Disorder
20-Dec-2012Vanda 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
19-Dec-2012Shire 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, ...
Phase II trial of GLYX 13 (Naurex) shows positive results in patients with Depression
08-Dec-2012Phase 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 ...
Suvorexant is filed at FDA by Merck Inc., for Sleep Disorder
10-Nov-2012A 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
30-Oct-2012A 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 ...
FDA approves Quillivant XR (Next Wave) for ADHD
03-Oct-2012The 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
28-Sep-2012Forest 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
24-Sep-2012Lundbeck 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 ...
New data for suvorexant (Merck Inc.) for treatment of Insomnia
12-Sep-2012Merck Inc., announced new data for suvorexant, the investigational medicine for the treatment of Insomnia. The new data are from one of the longest, continuously-dosed, placebo-controlled trials of a sleep medication ever conducted. This 12-month study was designed to assess the safety of suvorexant, while also evaluating its longer term efficacy. Merck presented new results from a two-month discontinuation ...
MK 4305 (Merck Inc.) data from two Phase III trials for Sleep Disorder
15-Jun-2012Merck 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
15-Jun-2012Vanda 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 ...
Phase III trials shows Vyvanse (Shire) effective in children and adolescents with ADHD
24-May-2012Results 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
15-May-2012Lundbeck 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 ...
Neurostar TMS therapy (Neuronetics) success in Depression
10-May-2012Patients 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 ...
Forest acquire Canadian rights to Savella and Bystolic
02-Apr-2012Forest Labs and Janssen terminated the licenses in Canada for both Bystolic and Savella (milnacipran) with Janssen Pharmaceutica NV and Janssen Pharmaceutical, respectively. Forest has now established its Canadian subsidiary, which will take over the registration and commercialization of both products....
US court rules that Seroquel XR patent (AstraZeneca) is valid
30-Mar-2012A 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.
28-Mar-2012The 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
27-Mar-2012Teva 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
24-Mar-2012The 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
20-Mar-2012AstraZeneca 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
09-Mar-2012Positive 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. ...
Intuniv (Shire) shows positive response for children with ADHD
13-Jan-2012A 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
20-Dec-2011AstraZeneca 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 approves Intermezzo (Transcept Pharmaceuticals) for use with middle-of-the-night Insomnia
25-Nov-2011The 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 ...
TC 5214 fails first Phase III trial for Major Depressive Disorder
10-Nov-2011Phase 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 ...
FDA finds ADHD drugs have no link to Cardiovascular problems
02-Nov-2011The 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
27-Oct-2011Novartis 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
26-Oct-2011New 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 ...
Vyvanse positive in European Phase III study for ADHD
21-Oct-2011Vyvanse- 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
08-Oct-2011Takeda 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)....
Somaxon may head for OTC status in USA for Insomnia
05-Oct-2011Somaxon 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
05-Oct-2011Transcept 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
17-Jul-2011The 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 ...
Advert for Healthcare Professionals only