News

Phase III study of Sufentanil NanoTab PCA System (AcelRx Pharmaceuticals) shows superiority to morphine for Pain relief

Clinical results from a Phase III trial of Sufentanil NanoTab PCA System, from AcelRx Pharmaceuticals, for the treatment of moderate-to-severe Acute Pain in the hospital setting demonstrate that sufentanil delivered via the NanoTab System has a significantly greater pain intensity reduction in the first four hours after treatment than IV PCA morphine (p<0.01).

In addition, there were fewer patients throughout ...

Phase II trial of ARX 04 Sufentanil NanoTabs (AcelRx Pharmaceuticals) meets endpoint for Acute Pain

Top-line results from a placebo-controlled, dose-finding, Phase II study of sublingual sufentanil NanoTab for Acute Pain, ARX 04, from AcelRx Pharmaceuticals, show that the treatment successfully met its primary endpoint. The study randomized 101 patients following bunionectomy surgery in a 2:2:1 ratio to 30 mcg sufentanil, 20 mcg sufentanil or placebo treatment arms. Results demonstrated that patients receiving 30 mcg ...

FDA approves Amitiza(Sucampo/Takeda) for Opioid-induced Constipation

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A., Inc. have announced that the FDA has approved Sucampo’s supplemental new drug application for Amitiza(lubiprostone) (24 mcg twice daily) as the first and only oral medication for the treatment of Opioid-induced Constipation (OIC) in adult patients with chronic, non-cancer pain. The effectiveness of Amitiza in the treatment of Opioid-induced Constipation in patients ...

Synera (Nuvo Research) significantly improves Pain in Shoulder Impingement Syndrome

New data on Synera (lidocaine and tetracaine) topical patch, from Nuvo Research, showed that Synera provided clinically significant improvement of Pain and function in Shoulder Impingement Syndrome (SIS). The data was a pooled analysis of two open label pilot studies of Synera. 70% of patients experienced a clinically meaningful reduction (more than a 30% reduction) in average pain scores. In ...

FDA approves new product labelling for OxyContin Controlled Release(Purdue Pharma) for Pain Management

Purdue Pharma L.P. has announced that the FDA has approved new language for the product label for OxyContin (oxycodone hydrochloride controlled-release) Tablets CII that describes abuse-deterrence studies conducted with the reformulated tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal ...

Study shows Ostinol (ZyCal Bioceuticals) improves pain and stiffness in Osteoarthritis

Results of the first double-blind, placebo-controlled study evaluating the benefits of Ostinol (cyplexinol), from ZyCal Bioceuticals, in alleviating symptoms of Osteoarthritis shows that this nutritional supplement decreases pain and stiffness, and offers an increase in quality of life as compared to placebo. Cyplexinol is a biologically active protein complex consisting of bone morphogenetic proteins which stimulate bone and cartilage growth ...

FDA approves Precision Spectra Spinal Cord Stimulator System (Boston Scientific) for treating Chronic Pain

The FDA has approved the Precision Spectra Spinal Cord Stimulator (SCS) System, from Boston Scientific, for treating Chronic Pain. The Precision Spectra System is the world's first and only SCS system with Illumina 3D software and 32 contacts, and is designed to provide improved pain relief to a wide range of patients who suffer from chronic pain. By providing 32 ...

Phase III success for Cymbalta (Eli Lilly) for Peripheral Neuropathy

Daily Cymbalta( duloxetine) therapy from Eli Lilly, was effective and well-tolerated for the treatment of painful Chemotherapy-induced Peripheral Neuropathy (CIPN), according to a randomized, double-blind, placebo-controlled Phase III trial presented at the 2012 American Society of Clinical Oncology Annual Meeting.

Patients were randomized to receive duloxetine followed by placebo (n=115) or placebo followed by duloxetine (n=116); initial crossover periods for ...

Phase II data shows CNV 1014802 (Convergence Pharmaceuticals) provides benefits for patients with Trigeminal Neuralgia

Interim data from the Phase II trial of CNV 1014802, from Convergence Pharmaceuticals, in patients with Trigeminal Neuralgia shows that the drug has a positive pharmacokinetic and safety profile for this pain condition. Eligible patients were entered into a 3-week open-label treatment period with CNV 1014802 at a dose of 150mg three times a day. If a successful response was ...

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 ...

Orexo sells US rights to Abstral to Galena Biopharma

Orexo AB has announced that it sold Abstral (fentanyl) Sublingual Tablets in the United States to Galena Biopharma, Inc. Under the terms of the agreement, Galena Biopharma will pay Orexo US$10 million upfront and an additional US$5 million within the first twelve months after signing, plus low double digit royalties and milestone payments based on pre-specified sales levels.

Abstral ...

EU approves expanded approval for Qutenza (Astellas) for Neuropathic Pain

The European Commission has approved expanded options for pre-treatment prior to use of Qutenza (8% capsaicin patch), from Astellas. Before application the patient may now take an oral analgesic, or the treatment area may be pre-treated with a topical anaesthetic. The 8% capsaicin patch is the first and only licensed high concentration (8%) capsaicin cutaneous patch for the treatment of ...

Paion AG initiates Phase II trial of remimazolam for Anaesthesia

Paion AG will conduct a Phase II trial with short acting anaesthic/sedative remimazolam in general anaesthesia in cardiac surgery in the second half of 2013.Ono Pharma have completed a successful Phase II trial for remimazolam in Japan in general aneasthesia and are conducting a Phase II/III trial.

The clinical studies performed with remimazolam comprise four Phase I and three Phase ...

Reanalysis of a trial of LipiGesic M (PuraMed Bioscience) suggests treatment is effective for Migraine

A reanalysis of clinical trial results of homeopathic formulation, LipiGesic M (feverfew and ginger), from PuraMed Bioscience, confirms that the Migraine medication can provide effective relief. The original double-blind, placebo-controlled clinical trial for LipiGesic M, completed in 2010 and published in the July 2011 issue of Headache: The Journal of Head and Face Pain, concluded that 64 percent of patients ...

Positive results in Phase III trial of Sufentanil NanoTab PCA (AcelRx Pharmaceuticals) for patients with Post-Operative Pain

Top-line data results demonstrating that the first of two pivotal placebo-controlled Phase III studies for sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System, from AcelRx Pharmaceuticals, met its primary endpoint. The primary endpoint evaluated Pain intensity over the 48-hour study period compared to baseline, or Summed Pain Intensity Difference (SPID-48), in patients following major open abdominal surgery.

Results demonstrated that patients ...

Moxduo (QRx Pharma) resubmitted to the FDA for approval for Pain control

QRx Pharma has resubmitted its Moxduo (morphine plus oxycodone) New Drug Application (NDA) to the FDA for the control of Pain. The FDA confirmed that there were no efficacy or safety issues in any of the studies that were part of the original NDA. The resubmitted application, including new results from Study 022, will undergo review by an Advisory Committee ...

Phase III trial of Naloxegol (AstraZeneca) confirms earlier safety studies in patients with Opioid-induced Constipation

New results from KODIAC-08, an open-label, randomised, 52-week, long-term safety trial of Naloxegol (naxolol), from AstraZeneca, in patients with non-cancer related pain and Opioid-induced Constipation, are similar to safety results seen in earlier Phase III studies. A total of 534 patients received Naloxegol daily for up to 52 weeks, while 270 patients received usual care. The most commonly reported AEs ...

FDA grants accelerated approval to Pomalyst (Celgene) to treat Multiple Myeloma

The FDA on 8 February 2013, approved Pomalyst (pomalidomide), from Celgene, to treat patients with Multiple Myeloma whose disease progressed after being treated with other cancer drugs. Pomalyst is a pill that modulates the body’s immune system to destroy cancerous cells and inhibit their growth. It is intended for patients who have received at least two prior therapies, including ...

FDA approves Focused Cold Therapy (myoscience) for patients with Peripheral Nerve Pain

The FDA has approved Focused Cold Therapy, from myoscience, for the treatment of Peripheral Nerve Pain. Focused Cold Therapy relies upon the science of cryoneuromodulation to precisely deliver cold to peripheral nerve tissue. It uses a device that resembles a magic marker pen, but which uses small needles to inject cryogenic material directly into the skin where it disrupts nerve ...

Phase III trial of OMS 103HP (Omeros Corp) shows pain reduction in patients after arthroscopic Surgery

New results from the first pivotal Phase III clinical trial evaluating OMS 103HP, from Omeros Corporation, in patients undergoing arthroscopic partial meniscectomy Surgery shows the drug provides significant reduction in pain. The trial's primary endpoint was the Symptoms Subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) – a patient-reported measure comprised of questions about knee swelling, clicking, catching ...

Phase III study of Sufentanil NanoTabs (AcelRX Pharmaceuticals) shows non-inferiority to morphine for Acute Pain

Top-line results of the Phase III clinical trial demonstrate that in treating Acute Pain, the Sufentanil NanoTab PCA System, from AcelRX Pharmaceuticals, was non-inferior to intravenous (IV) patient-controlled analgesia (PCA) with morphine as determined by the combined percentage of patients with Patient Global Assessment (PGA) ratings of "good" or "excellent" (78.5% vs. 66.1% respectively). This statistically superior PGA was also ...

FDA Advisory Committee rejects Zohydro for Chronic Pain treatment

The FDA Anasthetic and Analgesic Advisory Committee found Zohydro (hydrocodone bitartrate extended-release capsules)from Zogenix, was effective in managing Moderate to Severe Pain when a continuous round -the -clock opioid analgesic is needed but was not comfortable with the lack of an abuse deterrent mechanism and voted 11-2 to reject the drug....

Precision Spectra Spinal Cord Stimulator (Boston Scientific) receives CE Mark

Boston Scientific Corporation has received CE Mark approval and has begun the European market launch of the Precision Spectra Spinal Cord Stimulator (SCS) System. The Precision Spectra System is the world's first and only SCS system with 32 contacts and 32 dedicated power sources and is designed to provide improved pain relief to a wide range of patients who suffer ...

Positive results in Phase III trials of Naloxegol (AstraZeneca) for patients with Opioid Induced Constipation

Two Phase III trials and one safety extension trial of Naloxegol (naxolol), from AstraZeneca, in patients with non-cancer related pain and Opioid Induced Constipation (OIC) indicates that Naloxegol demonstrated statistically significant results for the primary endpoint, defined as having at least three Spontaneous Bowel Movements (SBM) per week, with at least one SBM per week increase over baseline. KODIAC-04 and ...

FDA approve ExAblate (InsighTec) to treat Pain from Bone Metastases

The FDA has approved ExAblate MRI-guided focused ultrasound, from InsighTec, as a therapy to treat Pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain. The ExAblate system integrates magnetic resonance imaging and high intensity focused ultrasound. FDA approval was based on the results of an international, multi-center, randomized clinical study comparing ...

Phase III results for ALO-02 (Pfizer) for moderate to severe Pain

Pfizer Inc. has announced top-line results from a Phase III open-label long-term safety study of investigational agent ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) in patients with moderate-to-severe chronic, non-cancer pain. The primary objective of the study was to evaluate the safety of ALO-02 administered for up to 12 months. The study showed that the adverse event profile was ...

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 ...

EMA 401 has Phase II success for Post Herpetic Neuralgia

There have been positive headline results from the Phase II clinical trial of EMA 401 from Spinifex Pharmaceuticals, in Postherpetic Neuralgia (PHN), a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals. The clinical trial met its primary endpoint, reduction in mean daily pain score versus placebo ...

FDA approves WiTouch (Hollywog) for Chronic Back Pain

The FDA has issued two 510(k) clearances allowing Hollywog to market its WiTouch and WiTouch Pro wireless remote controlled devices for Chronic Back Pain. The WiTouch devices are the first wireless remote controlled pain relief device incorporating TENS technology to specifically target back pain. The WiTouch is cleared for over-the-counter, and the WiTouch Pro is cleared for prescription use. An ...

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 requests further data in review of Relistor (Salix) for Opioid-induced Constipation

The FDA have provided a Complete Response Letter (CRL) following its review of a Supplemental New Drug Application (sNDA) for Relistor (methylnaltrexone bromide), from Salix, for the treatment of Opioid-induced Constipation in adult patients with chronic, non-cancer pain. The CRL requests additional clinical data. Salix and Progenics intend to request an End-of-Review meeting with the Division of Gastroenterology and Inborn ...

FDA accepts filing of Zohydro ER for Chronic Pain treatment

The FDA has accepted for review the new drug application (NDA) for the oral, extended-release hydrocodone therapy ZohydroER from Zogenix Inc., as a treatment for moderate to severe Chronic Pain.The FDA set 1 March 2013 as the Prescription Drug User Fee Act action date – granting a 10-month standard review....

FDA approves Lyrica (Pfizer) for management of pain associated with Spinal Cord Injury

The FDA has approved the use of Lyrica (pregabalin) capsules CV from Pfizer for the management of Neuropathic Pain associated with Spinal Cord Injury. Lyrica received a priority review designation for this new indication from the FDA. More than 100,000 patients – approximately 40 percent of the 270,000 patients with Spinal Cord Injury in the United States - suffer from ...

FDA approves Horizant (GlaxoSmithKline/XenoPort) for Postherpetic Neuralgia in adults

The FDA has approved Horizant (gabapentin enacarbil) extended-release tablets, from GlaxoSmithKline / XenoPort, for Postherpetic Neuralgia in adults. Approval is based on a single 12-week principal efficacy trial, plus two supportive studies that all met their respective primary endpoints. The three clinical studies involved 574 adult patients from the US, Canada and Germany. Somnolence and dizziness were the most frequently ...

Orexo AB regains US marketing rights to Abstral

Orexo AB have regained from 1 January 2013 US rights to market Abstral (fentanyl citrate sublingual) from Kyowa Hakko Kirin/ProStraken. The emphasis in marketing in the US will now be on pain specialists and not oncologists. ProStraken is a company focused on oncology. Abstral will be followed in the US by OX 219, a treatment for opioid dependence. OX 219 ...

CHMP provides advice for AmiKet (EpiCept Inc) MAA in treatment of Peripheral Neuropathy

The CHMP has provided scientific advice for development and subsequent Marketing Authorization Approval (MAA) filing of AmiKet (amitriptyline 4%, ketamine 2%), from EpiCept Inc., for the treatment of chemotherapy-induced Peripheral Neuropathy (CIPN). It recommended that the proposed clinical program consist of a single 12-week, four-arm, factorial-designed trial in CIPN that would seek to demonstrate AmiKet’s superiority compared with placebo and ...

Nucynta (J&J Janssen) provides pain management for Patients with Diabetic Peripheral Neuropathy

A Phase III study suggests Nucynta ER (tapentadol) tablets, from J&J Janssen, were significantly more effective than placebo in providing pain management among adults with chronic moderate to severe, painful Diabetic Peripheral Neuropathy (DPN). This trial had three phases: an open-label phase, in which the individually optimized tapentadol ER dose (100-250 mg two times per day) was determined for each ...

VEN 307 success Iin Phase III trial for Anal Fissure Pain

VEN 307(diltiazem crean) from S.L.A.Pharma met the primary endpoint in a pivitol Phase III study, showing a statistically significant reduction in Anal Pain on defecation after four weeks compared to placebo. Both 4% and 2% diltiazem cream arms demonstrated statistically significant improvement over placebo for change in week four NRS for worst anal pain. Reduction in pain score was 0.44 ...

Phase III Trial of Lyrica (Pfizer) for Neuropathic Pain with HIV halted

A Phase III clinical trial of Lyrica (pregabalin), from Pfizer, in patients with Neuropathic Pain associated with HIV neuropathy has been halted. The decision follows review of a planned interim analysis of the study by the trial’s external Data Monitoring Committee (E-DMC). There were no safety concerns raised in the E-DMC review of the interim data. The protocol for study ...

Zogenix files NDA with FDA for Zohydro Chronic Pain treatment

Zogenix has submitted an New Drug Application (NDA) to the FDA for Zohydro (hydrocodone bitartrate extended-release capsules) for the treatment of Chronic Pain. Zohydro, classified as a Drug Enforcement Agency Schedule II drug product, would carry more strict prescription and dispensing rules as compared to the currently available hydrocodone combination products. In addition, Zogenix has included in the NDA a ...

Amitiza (Sucampo/Takeda) success in Phase III safety trial for OBD

Top line results are reported by Sucampo Pharma from an open-label 439 patient, 36 week, Phase III clinical trial designed to evaluate the long-term safety and efficacy of Amitiza (lubiprostone) for patients with Opioid-Induced Bowel Dysfunction (OBD) in subjects with chronic, non-cancer pain, excluding those taking methadone.Lubiprostone met the primary endpoint of demonstrating overall safety and secondary endpoints, including changes ...

Forest acquire Canadian rights to Savella and Bystolic

Forest 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....

Alcon acquires non USA rights to Ocriplasmin for Vitreomacular Adhesion

Alcon,a division of Novartis, has announced that it has gained exclusive rights from ThromboGenics, to commercialize ocriplasmin outside the United States for the treatment of Symptomatic Vitreomacular Adhesion (VMA). If approved, it will be the first pharmacological treatment for patients with symptomatic VMA, including macular hole. Symptomatic VMA is a progressive, debilitating eye disease that may lead to visual distortion, ...

FDA approves Binosto (EffRx) for Osteoporosis

The FDA has approved Binosto (alendronate sodium) Effervescent Tablets, previously known as EX101, for the treatment of Osteoporosis in postmenopausal women, and as a treatment to increase bone mass in men with Osteoporosis. EffRx anticipates that Binosto will be commercially available in the United States in the third quarter of 2012. Binosto was developed by EffRx based on an agreement ...

Shire withdraws FDA application for Replagal for Fabry Disease

Shire has withdrawn its Biologics License Application (BLA) for Replagal (agalsidase alfa) with the FDA. Shire has been in ongoing dialogue with the FDA since the supply shortage of the only USA approved treatment for Fabry disease. In 2009, and again in 2011, the FDA encouraged Shire to submit an application for the approval of Replagal. Recent interactions with the ...

Ulimorelin (Tranzyme) fails in ULISES 007 trial for Post Operative Ileus

The intravenous ghrelin agonist, ulimorelin, from Tranzyme Pharma/Norgine failed to meet its primary efficacy endpoint of accelerating recovery of GI function versus placebo in the Phase III ULISES 007 trial of subjects who have undergone bowel resection surgery. In the ULISES 007 trial ulimorelin was given at either 160mcg or 480mcg and was not statistically different from the placebo group ...

BioDelivery Sciences Intl licenses BEMA buprenorphine to Endo Pharma for mild to severe Chronic Pain

BioDelivery Sciences International (BDSI) has licensed the world rights of BEMA buprenorphine to Endo Pharmaceuticals. BEMA buprenorphine is a treatment for moderate to severe chronic pain which blends the opioid analgesic buprenorphine with the BioErodible MucoAdhesive (BEMA) drug delivery technology. A bioerodible polymer film about the size of a fingertip attaches to the inner lining of the cheek. The film ...

FDA approves Opana ER from Endo Pharma for Moderate to Severe Pain

The FDA has approved a new, harder-to-abuse formulation of Opana ER, the extended-release oxymorphone drug that is crush resistant from Endo Pharma for Moderate to Severe Pain. There have been generic versions of immediate release and extended release oxymorphone on the market for many years. The Endo Pharma version is distinguished by its "harder ro abuse " formulation which is ...

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 ...

Lexapro/Cipralex (Forest Labs/Lundbeck) reduces Pain in opiod-dependent patients

Opioid-dependent patients treated with Lexapro/Cipralex (escitalopram), from Forest Labs and Lundbeck, experience meaningful reductions in pain severity and pain interference during the first three months of therapy, according to a study published in Pain. Among methadone-treated patients, estimates of chronic pain prevalence range between 37-61 percent. Management of pain in opioid-dependent patients is a clinical challenge given concerns for opioid ...

Lower dose of corticosteroids as effective as higher dose for Shoulder Pain

A study of two common corticosteroid doses administered for Shoulder Pain reveals that lower doses are as effective as higher ones for pain reduction, duration of efficacy and improved range of motion. Investigators led by Seung-Hyun Yoon, from the Department of Physical Medicine and Rehabilitation, Ajou University School of Medicine, Suwon, Republic of Korea, conducted a clinical trial in which ...

Exparel is FDA approved for Post Surgical Analgesia

Exparel(bupivacaine extended-release liposome injection),a non-opioid local analgesic, is FDA approved for post-surgical analgesia. Exparel provides analgesia for several days with a single intraoperative infiltration. The approval is based on a trial that showed a larger percentage of patients treated with Exparel avoided opioid rescue medication during the first 24 hours after surgery compared to placebo,,7% versus 1%. Exparel combines bupivacaine ...

Implanted SPR Micropulse System shows benefit for patient with Post-Stroke Shoulder Pain

Doctors involved in a multi-centre clinical study for the treatment of Post-Stroke Shoulder Pain have made the first implantation of the Micropulse system, an investigational pain therapy device from SPR Therapeutics. SPR's short-term, temporary therapy significantly reduced his pain after just a few weeks but when SPR's fully implantable device was implanted into the patient, he was pain-free within a ...

EU Commission approves Dexdor for sedation of patients in Intensive Care

European Commission has granted Dexdor (dexmedetomidine) from Orion, centralised approval covering 27 European Union countries for sedation of adult intensive care unit patients requiring a level of sedation not deeper than arousal in response to verbal stimulation. The company plans to begin a European launch in Germany and Austria in early 2012. It will launch much later in other European ...