Pierre Fabre Laboratories announced that the Food and Drug Administration (FDA) has just approved the marketing application filed by Forest Laboratories, Inc. and Cypress Bioscience, Inc. for Milnacipran.
Milnacipran is a selective serotonin and noradrenalin dual reuptake inhibitor developed by Pierre Fabre, which granted the rights for North America to Cypress Bioscience and Forest for the management of fibromyalgia.
“It’s excellent news for American patients since fibromyalgia affects nearly 6 million people in the United States and few treatments are available. Moreover, this approval is crucial for Pierre Fabre Laboratories as Milnacipran is one of the flagship products of the company’s portfolio. It is the 2nd product of Pierre Fabre research registered in the United States” says Jean-Pierre Garnier, CEO of Pierre Fabre SA.
The FDA approval is based on two pivotal phase III clinical studies that have established the tolerance and efficacy of Milnacipran for the management of fibromyalgia.
In these studies, involving over 2,000 patients suffering from fibromyalgia, Milnacipran doses of 100 mg and de 200 mg showed clinically significant improvement of pain, global patient assessment and physical function.
Milnacipran is the product of a unique clinical development program, one that considered a patient to be a responder to therapy only if they demonstrated concurrent and clinically significant improvement in all this three aspects of fibromyalgia. Milnacipran is the only product approved for the management of fibromyalgia that used this complete responder analysis as its primary endpoint.
In addition, Milnacipran was generally well tolerated, the majority of its side effects ranging from only slight to moderate.
In Europe, Pierre Fabre Laboratories have filed an application with the European Medicines Agency for the same indication in June 2008 with European market approval targeted for 2009.
Source: Pierre Fabre, USA