Forest Laboratories, Inc and Cypress Bioscience, Inc. jointly said that the companies have recently submitted a new drug application (NDA) for Milnacipran, a unique dual-reuptake inhibitor being developed for the treatment of fibromyalgia syndrome (FMS), to the US Food and Drug Administration (FDA).
As per the available data, the companies have submitted 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 FMS to the FDA.
The advantage is that the safety data collected from 2,209 patients (1,557 milnacipran, 652 placebo) during the development programme demonstrated that milnacipran was generally well tolerated with the majority of adverse events reported as mild to moderate in nature.
Milnacipran is a unique dual-reuptake inhibitor, which 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 US for 10 years.
Milnacipran is jointly being developed for fibromyalgia syndrome in the United States market by Forest and its licensor Cypress Bioscience. Milnacipran was originally developed by and is sold outside of the US by Pierre Fabre Medicament.
Fibromyalgia syndrome is defined by widespread chronic pain, as well as a broad spectrum of related symptoms including fatigue, cognitive dysfunction and reduced physical function. 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.
Fibromyalgia syndrome is a chronic and debilitating condition characterised by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. According to the American College of Rheumatology, FMS is estimated to affect over six million people in the United States. FMS is most often diagnosed in the primary care setting and, in addition, is the second most commonly diagnosed condition in rheumatology clinics in the United States after osteoarthritis.
Despite the high prevalence and severity of this syndrome, there are limited treatment options specifically approved for FMS in the United States or elsewhere, and the addressable patient population is not yet well established.