Forest and Cypress file milnacipran for FMS

US companies Forest Laboratories and Cypress Bioscience have recently submitted a New Drug Application to the Food and Drug Administration for milnacipran, a unique dual-reuptake inhibitor being developed for the treatment of fibromyalgia syndrome.

FMS is defined by widespread chronic pain, as well as a broad spectrum of related symptoms including fatigue, cognitive dysfunction and reduced physical ability. 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. This approach is considered a more stringent assessment of therapeutic effect than the evaluation of individual symptoms.

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