Forest Laboratories announces positive phase III milnacipran results

Together with Cypress Bioscience, Forest Laboratories has announced positive initial top-line results for a phase III clinical study of milnacipran as a treatment for fibromyalgia syndrome, with the company anticipating further analysis of the trial in the near future.

Cypress Bioscience aims to in-license or acquire central nervous system compounds before developing them for new indications, with a focus on fibromyalgia syndrome and other functional somatic diseases.

Patients in the study were administered with milnacipran or placebo with primary endpoints being the treatment of fibromyalgia syndrome and the pain associated with the condition.

In the trial, patients administered with milnacipran reported a self-assessment of having pain “much” or “very much” reduced, while exhibiting a minimum of 30 per cent drop in pain measured by a visual analogue scale.

Milnacipran – a treatment approved for depression in 32 countries worldwide – is a compound belonging to a new class of norepinephrine serotonin reuptake inhibitors that operates through the selective inhibition of norepinephrine over serotonin to affect pain and mood.

“The treatment of pain associated with fibromyalgia is assessed by evaluating pain as measured by the Patient Experience Diary and the overall impression of patient well being as measured by the Patient Global Impression of Change for patients receiving either dose of milnacipran compared to placebo,” Forest Laboratories stated.

In January 2007, Forest Laboratories and Cypress Bioscience announced the initiation of phase III clinical trials of milnacipran with some modifications following early studies at this level showing limited effectiveness of the compound.