Theravance reports Phase II fibromyalgia data

Theravance Inc. (NASDAQ:THRX) reported results late Wednesday from a 392-patient Phase II trial evaluating once-daily TD-9855 to treat fibromyalgia. Once-daily 20 mg TD-9855 met the primary endpoint of reducing from baseline the average daily pain score during the last week of the six-week treatment period vs. placebo (p=0.022). The once-daily 5 mg dose of TD-9855 missed the primary endpoint. Theravance could not be reached for next steps for the compound in the indication. Last year, the company discontinued development of TD-9855 to treat ADHD after the norepinephrine and serotonin reuptake inhibitor (NSRI) missed the primary endpoint in a Phase II trial.

This quarter, Theravance expects to complete its split into two publicly traded companies: one will focus on discovery and R&D of small molecules and will house TD-9855; and the other company will house Theravance's partnered late-stage respiratory assets. ...