Forest/Cypress to start third Ph III milnacipran trial

US firms Forest Laboratories and Cypress Bioscience have said they will initiate a third randomized, double-blind, placebo-controlled pivotal Phase III study evaluating milnacipran as a treatment for fibromyalgia (FMS) in the first quarter of 2006.

In addition, the companies announced that, based on an analysis of the results from the first Phase III trial, which was supportive of milnacipran's effect in fibromyalgia patients, certain modifications have been made to the ongoing second Phase III evaluation. These modifications include increasing the size of the second study from approximately 800 patients to 1,200 patients. Based on the anticipated time necessary to recruit the additional patients, the firms expect to announce initial results from the second Phase III study no earlier than mid-calendar 2007.

Milnacipran is the first of a new class of agents known as norepinephrine serotonin reuptake inhibitors, or NSRIs, which exerts its effect by preferentially inhibiting the reuptake of norepinephrine over serotonin, two neurotransmitters known to play an essential role in regulating pain and mood. It has been approved for the treatment of non-pain indications in 32 countries and has been used safely by over three million patients during more than six years of commercial availability outside the USA, according to the firms.