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 -

Forest Laboratories and Cypress Bioscience : FDA Defers Final Action on milnacipran New Drug Application

Oct 20, 2008 - Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB) (the "Companies") announced that the U.S. Food and Drug Administration (FDA) has advised the Companies that it was not able to take final action by the scheduled Prescription Drug User Fee Act action date of October 18, 2008, on their New Drug Application for milnacipran, a selective serotonin and norepinephrine reuptake inhibitor for the management of fibromyalgia.

The FDA has not requested any additional information from the Companies but did indicate that a clinical data question related to the NDA submission required confirmation. The FDA indicated that their assessment could be completed in a matter of weeks, but could not confirm specific timing. The FDA could not provide further information as to the reason for the delay. The Companies continue to plan for a first quarter 2009 product launch meeting... Forest Laboratories' Press Release - [PDF] Cypress Bioscience's Press Release -