Pfizer : Positive Results From Phase 3 Trial Of Lyrica (pregabaline) Capsules CV In Restless Legs Syndrome

December 16, 2011 - Top-Line Results Show Lyrica Met All Co-Primary Endpoints -
Pfizer Inc. (NYSE: PFE) announced that a Phase 3 study for Lyrica (pregabalin) in patients with Restless Legs Syndrome (RLS) met each of its three co-primary endpoints, showing significant benefit as compared with placebo and pramipexole. Pfizer will continue to further analyze these top-line results.

The study, A0081186, was a randomized, double-blind, 12-month trial. It enrolled more than 700 patients, who received either a placebo, Lyrica at 300 mg/day, pramipexole at 0.25 mg/day or pramipexole at 0.5 mg/day.

Patients treated with Lyrica experienced a statistically significant improvement compared with placebo in RLS symptom severity as measured by the International Restless Leg Group Rating Scale following 12 weeks of treatment. The Lyrica group also demonstrated a statistically significant improvement following 12 weeks of treatment in the proportion of patients responding to treatment compared with those on placebo as measured by the Clinical Global Impression Improvement scale. In addition, Lyrica treatment resulted in a statistically significant reduction in the rate of augmentation (worsening of RLS symptoms that occur after starting a medication to treat RLS) compared with pramipexole 0.5 mg/day over 12 months.

The results for this study indicate that the most common adverse events in Lyrica-treated patients were dizziness, somnolence, fatigue, headache and nasopharyngitis (inflammation of the nasal cavity and throat). The adverse event profile is consistent with that known for pregabalin.

Restless Legs Syndrome is a neurological condition that is characterized by an unpleasant irresistible urge to move the legs and, in severe cases, other parts of the body. The symptoms have a circadian pattern and occur mostly in the evening and bedtime. It often results in difficulty falling or staying asleep and can result in periodic limb movements while sleeping, causing partial awakenings that disrupt sleep. RLS has profound negative impact on patients’ quality of life... Pfizer's Press Release -

Impax Pharmaceuticals : Phase IIb Trial of IPX159 in Restless Legs Syndrome

Dec. 19, 2011-- Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced that it has initiated a Phase IIb trial of its drug candidate IPX159 in patients with moderate to severe Restless Legs Syndrome (RLS).

“We are pleased to advance IPX159 to this Phase IIb study, which will help establish its clinical profile in moderate to severe RLS patients. We look forward to reporting the results from this study and providing an update on the program in mid-2013,” said Suneel Gupta, Ph.D., chief scientific officer, Impax Pharmaceuticals.

The Phase IIb study is a multicenter, randomized, double-blind, placebo-controlled, safety and efficacy study to evaluate IPX159 in the treatment of moderate to severe RLS. The trial is expected to randomize approximately 120 adult subjects who will receive either IPX159 or placebo and will be treated for up to 11 weeks. The trial will be conducted at multiple sites in North America. The primary endpoint is the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale... Impax Pharmaceuticals' Press Release -

Astellas and XenoPort : Submission of a New Drug Application in Japan Requesting PMDA Approval of ASP8825/XP13512 for Restless Legs Syndrome

Nov. 19, 2009-- Astellas Pharma Inc. and XenoPort, Inc. (NASDAQ:XNPT) announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS).

The data supporting safety and efficacy in the NDA filing comes from the successful Phase 2 study in RLS patients and long-term safety study conducted by Astellas in Japan and the RLS clinical program conducted by XenoPort in the United States. The acceptance of filing of the NDA triggers a $5 million milestone payment from Astellas to XenoPort... [PDF] Astellas Pharma's Press Release - XenoPort's Press Release -

Omeros and The Parkinson's Institute : Collaboration Agreement to Evaluate Novel Target for the Treatment of Movement Disorders

September 17, 2008 – Omeros Corporation and The Parkinson’s Institute and Clinical Center announced that they have entered into a collaboration to evaluate a novel target, proprietary to Omeros, for the treatment of movement disorders. The collaboration is based on Omeros’ discovery and prior validation of a previously unknown link between this molecular target in the brain and movement disorders such as Parkinson’s disease and Restless Legs Syndrome (RLS)... [PDF] Omeros' Press Release -

Neurogen : Positive Results for Aplindore in Restless Legs Syndrome and Parkinson's Disease

Oct. 14, 2008 - Neurogen Corporation (Nasdaq: NRGN) announced positive top-line results from two Phase 2 clinical trials in restless legs syndrome (RLS) and Parkinson's disease with the Company's dopamine partial agonist, aplindore. These studies were the first in which aplindore has been evaluated in RLS and Parkinson's disease.

In each study, aplindore demonstrated highly significant efficacy and was well tolerated. Neurogen believes aplindore's dopamine partial agonist controlled release profile may be better tolerated, with fewer side effects and greater dosing flexibility, than existing drugs to treat RLS and Parkinson's disease. Side effects of RLS drugs currently on the market or in late-stage development include daytime somnolence, dizziness and nausea. These drugs require titration, or slow escalation of doses, over several days or weeks to achieve an effective dose. Side effects of drugs currently available for the treatment of Parkinson's disease include nausea, somnolence, hallucinations and dyskinesias, or involuntary movements, and also require titration to reach therapeutic doses... Neurogen' Press Release -

GlaxoSmithKline & XenoPort : submission of new drug application requesting FDA approval of Solzira™ for Restless Legs Syndrome

September 16, 2008 - GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) announced that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira™ (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). RLS affects an estimated 12 million people in the United States and can result in distressing symptoms that disrupt sleep and significantly impact daily activities.

Solzira is a non-dopaminergic new chemical entity that provides improvement in the symptoms of RLS with the convenience of a once-daily formulation... GlaxoSmithKline's Press Release - XenoPort's Press Release -

Boehringer Ingelheim : Pramipexole clinical trial programme in Restless Legs Syndrome (RLS) reveals new significant results

26 August 2008 – Results from a large pramipexole trial programme in Restless Legs Syndrome (RLS) conducted by Boehringer Ingelheim were presented at the 12th European Federation of Neurological Societies (EFNS) Annual Congress held in Madrid, Spain, from 23 to 26 August. The results of two large Phase IV trials showed that while pramipexole significantly improves the characteristic symptoms of RLS among patients with moderate to severe RLS, it also demonstrated significant beneficial effects on associated symptoms such as limb pain and health-related quality of life, including associated mood disturbance. Limb pain and mood disturbance are important secondary ailments commonly experienced by RLS patients, and these studies are the first in which an approved RLS treatment has demonstrated benefits addressing these symptoms in a clinical study in RLS patients... Boehringer Ingelheim's Press Release - Boehringer Ingelheim's Press Release -

UCB : Neupro recommended for approval in Europe for Restless Legs Syndrome

25 April, 2008 - UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending that the European Commission grants a marketing authorisation for Neupro® (rotigotine transdermal patch) in the symptomatic treatment of moderate-to-severe idiopathic Restless Legs Syndrome (RLS) in adults.
The CHMP decision is based on data from two well-controlled clinical trials that evaluated the efficacy and safety of Neupro® over a six month period in almost 1,000 patients with RLS. In these trials, Neupro® showed significant and clinically relevant improvements in RLS symptoms compared to placebo and was generally well tolerated... UCB's Press Release -

XenoPort and GlaxoSmithKline : XP13512/GSK1838262 Significantly Improved Symptoms of Moderate-to-Severe Primary Restless Legs Syndrome

April 17, 2008 - Data from the first pivotal study of XP13512/GSK1838262, a sustained-release investigational compound to treat Restless Legs Syndrome (RLS), showed that it significantly improved the symptoms of moderate-to-severe primary RLS compared to placebo, and was generally well-tolerated when administered once-daily for 12 weeks Data from the PIVOT RLS I (Patient Improvement in Vital Outcomes following Treatment for RLS) clinical trial, formerly designated as study XP052, were presented today at the 60th annual meeting of the American Academy of Neurology (AAN). The investigational compound is being developed by XenoPort (Nasdaq: XNPT) - GSK.

"This novel compound is the first non-dopaminergic agent to demonstrate efficacy in treating the symptoms of RLS in large controlled clinical trials... XenoPort's Press Release -

Neurogen : $30.6 Million Financing to Advance Clinical Development Programs

Apr 09, 2008 - Neurogen Corporation (Nasdaq: NRGN) announced it has entered into definitive agreements for a private placement offering of exchangeable preferred stock and warrants with selected institutional investors for gross proceeds of approximately $30.6 million before fees and expenses...
..."Our clinical portfolio is expanding and advancing as we leverage the potential of adipiplon and aplindore in several indications. We began Phase 2 studies in both Parkinson's disease and RLS with aplindore earlier this year. An upcoming Phase 2/3 study with adipiplon for insomnia enables us to examine how our drug compares to the current market leader, Ambien CR(TM), in a side-by-side comparison study. We will also run a human proof-of-concept study in anxiety to examine adipiplon's ability to relieve anxiety at doses substantially below those that produce sedation--an exciting finding we have observed in animal studies. We anticipate data from all four programs by the end of the year."... Neurogen's Press Release -

Jazz Pharmaceuticals, Inc. : Development Pipeline Progress

March 13, 2008 - Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) provided a comprehensive update on its commercial activities and near-term product development pipeline, and provided 2008 financial guidance, for investors and analysts at its Investor Day meeting in New York City...
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...Jazz Pharmaceuticals' sales representatives currently promote XYREM(R) (sodium oxybate) for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy to sleep specialists, neurologists and psychiatrists. XYREM net sales increased by 34 percent, from $29 million in 2006 to $39 million in 2007. XYREM net sales are expected to be in the range of $45 million to $55 million during 2008....
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... Jazz Pharmaceuticals announced that JZP-7, a proprietary transdermal gel formulation of ropinirole, is designed to provide an effective, once-a-day treatment of moderate to severe restless legs syndrome. JZP-7 has been successfully evaluated in one pharmacokinetic (PK) study, and a second PK study is near completion. Available results from both studies demonstrate that the product is well tolerated. Jazz Pharmaceuticals is currently planning to initiate a Phase III clinical trial in the fourth quarter of 2008. Restless legs syndrome affects up to 10 percent of the U.S. population... Jazz Pharmaceuticals' Press Release -

XenoPort and GlaxoSmithKline, Second Phase 3 Restless Legs Syndrome Trial for XP13512/GSK1838262

Jan 15, 2008 - XenoPort, Inc. (Nasdaq:XNPT) and GlaxoSmithKline (NYSE:GSK) announced positive top-line results from a placebo-controlled Phase 3 clinical trial designed to evaluate the potential of XP13512 (GSK1838262) to maintain efficacy over the course of nine months in patients with moderate-to-severe primary Restless Legs Syndrome, or RLS... XenoPort's Press Release - GlaxoSmithKline 's Press Release-

UCB's Neupro, Filed with the FDA for the Treatment of Restless Legs Syndrome

December 12, 2007 - UCB announced that the supplemental New Drug Application (sNDA) for the use of Neupro as a treatment for moderate-to-severe restless legs syndrome (RLS) has been accepted for filing by the U.S. Food and Drug Administration (FDA)...Restless Legs Syndrome is a chronic neurological disorder that affects between three and ten per cent of the population...Symptoms of RLS typically appear during periods of rest and inactivity, particularly in the evenings and at night. This can make it difficult to fall asleep and stay asleep, thus preventing recuperative sleep and often leading to daytime fatigue and reduced alertness... UCB's Press Release -