Forest and Cypress submit NDA for CNS drug

The submission includes efficacy data from two pivotal Phase III trials involving 2,084 patients (1,460 milnacipran, 624 placebo), which showed that milnacipran demonstrated improvement compared to placebo in treating fibromyalgia syndrome (FMS). Moreover, safety data collected from 2,209 patients (1,557 milnacipran, 652 placebo) during the development program demonstrated that milnacipran was generally well tolerated with the majority of adverse events reported as mild to moderate in nature.

The NDA for milnacipran is based on a composite responder analysis that requires each patient to experience concurrent and clinically meaningful improvements in three validated measures: pain, patient global impression of change in disease status, and physical function.