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 -

Pierre Fabre Médicament : JONCIA® milnacipran treating fibromyalgia in Australia

On November 17 in Australia, Pierre Fabre Médicament obtained marketing authorization for Joncia® milnacipran in the treatment of fibromyalgia.

Australian drug regulation agency the Therapeutic Goods Administration (TGA) has granted Pierre Fabre Médicament marketing authorization for Joncia® milnacipran, a molecule used in the treatment of fibromyalgia. First discovered by Pierre Fabre's research teams, milnacipran has since been developed for this indication in collaboration with Cypress Bioscience (acquired by Royalty Pharma) and Forest Laboratories.

Approval was granted on the basis of three 3-month Phase III clinical trials conducted in the United States and Europe. These studies, involving over 3,000 patients evaluated using a self-assessment questionnaire, revealed that 100 mg and 200 mg doses of milnacipran resulted in a clinically significant reduction in pain, an overall improvement in symptoms, and a significant improvement in fatigue and sleep. In addition Milnacipran was generally well tolerated with most adverse events being recorded as mild to moderate, and the TGA has announced a positive Joncia® milnacipran benefit/risk ratio... Pierre Fabre Médicament's Press Release -