Forest Laboratories and Cypress Bioscience are celebrating the news that regulators in the USA have given the go-ahead to the firm’s milnacipran for the treatment of fibromyalgia.

The companies have announced that Savella (milnacipran), a selective serotonin and norepinephrine dual reuptake inhibitor, has been approved by the US Food and Drug Administration for the management of fibromyalgia, a chronic condition characterised by widespread pain and decreased physical function. It afflictis as many as six million people in the USA.

The approval of Savella is based on data from two Phase III trials involving over 2,000 patients with the condition. The studies showed that doses of 100 mg/day and 200 mg/day demonstrated “statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment, and physical function”.

The approval also represents good news for France’s Pierre Fabre, which originally developed and sells milnacipran outside the USA as an antidepressant. It licensed the rights for North America to Cypress and the French firm’s chief executive Jean-Pierre Garnier, said the approval is “crucial” for the company.

Cypress first licensed the rights to Savella in 2001 from Pierre Fabre and then signed a deal in 2004 with Forest which saw the firms collaborate on late-stage clinical trials, submission of the New Drug Application and for marketing. Under the terms of that agreement, Cypress stands to receive as much as $205 million from Forest following approval.

Savella is expected to reach pharmacies in March and will fight for market share against the other two drugs approved for fibromyalgia – Pfizer’s Lyrica (pregabalin) and Eli Lilly's Cymbalta (duloxetine).