Forest/Cypress submit NDA for milnacipram

Forest Laboratories and fellow USA-based Cypress Bioscience say that the Food and Drug Administration has accepted for review their New Drug Application for milnacipran for the treatment of fibromyalgia. With a standard 10-month review timeline, a decision is expected by the end of October.

The companies submitted their NDA 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 it is 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, the firms noted. The agent 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, the firms noted.