The Companies submitted their NDA for milnacipran for the treatment of fibromyalgia syndrome based on results from a composite responder analysis requiring that each patient experienced concurrent and clinically meaningful improvements in three validated measures: pain, patient global impression of change in disease status, and physical function. The FDA advised that they are moving toward class labeling for drugs used to treat fibromyalgia, with any distinctions among therapies reflected in specific product labels instead of differences in the approved indications.

About Milnacipran

Milnacipran is a unique dual-reuptake inhibitor that preferentially blocks the reuptake of norepinephrine with higher potency than serotonin, two neurotransmitters known to play an essential role in regulating pain and mood. It has been approved for a non-pain condition in over 50 countries, with real-world commercial experience outside the U.S. for 10 years. Milnacipran is jointly being developed for fibromyalgia in the United States market by Forest and its licensor, Cypress Bioscience, Inc. Milnacipran was originally developed by and is sold outside of the U.S. by Pierre Fabre Medicament. Fibromyalgia is defined by widespread chronic pain, as well as a broad spectrum of related symptoms including fatigue, cognitive dysfunction, and reduced physical function.