TD-9855: Phase II data

A double-blind, U.S. Phase II trial in 392 patients with fibromyalgia showed that once-daily 20 mg TD-9855 met the primary endpoint of reducing the average of daily pain score from baseline during the last week of the 6-week treatment period vs. placebo (1.4 vs. 0.9 points, p=0.022). The once-daily 5 mg dose of TD-9855 missed the primary endpoint. High-dose TD-9855 also met the secondary endpoints of reducing FIQ score from baseline to day 43 (16.2 vs. 10.4 points, p=0.01) and of improving the proportion of patients with a PGIC rating of "much improved" or "very much improved" at day 43 (48% vs. 32%, p=0.015) vs. placebo. Theravance also said high-dose TD-9855 showed "positive treatment effects" on exploratory global fatigue and cognitive fatigue endpoints. Theravance said the "results provided a desirable outcome of identifying both effective and sub-effective dose of TD-9855."

Both doses of TD-9855 were generally well tolerated. The most common treatment-emergent adverse events reported were headache, nausea, dizziness, insomnia and constipation. There were 2 serious adverse events reported in the TD-9855 groups, with 1 assessed as possibly related to 5 mg TD-9855. Theravance said it will complete a full analysis of the data and discuss with regulatory authorities before determining next steps, but that top-line data support further development of TD-9855 in the indication. ...