Pierre Fabre submits MAA for milnacipran on strong Ph III data

Pierre Fabre Medicament presented positive data from a Phase III study of milnacipran fibromyalgia in adult patients. The French drugmaker also announced that it has submitted a Market Authorization Application to the European Medicines Agency (EMEA) for the unique dual-reuptake inhibitor for fibromyalgia syndrome. The primary efficacy assessment in the Phase III study was a composite responder rate based on: a 30% reduction in pain from baseline in the 24-hour recall pain score recorded on an electronic diary and patient global impression of change as very much or much improved. At the end of the 12-week, fixed-dose period, when compared with placebo, milnacipran showed a much greater improvement in the primary efficacy composite endpoint measure (p=0.0003), the company noted.