Theravance Inc. announced positive topline results from 0084, the key study in the Phase 2b program evaluating TD-1211 as a potential treatment for chronic, non-cancer pain patients with opioid-induced constipation (OIC). TD-1211 is an investigational, orally administered, peripherally selective, multivalent inhibitor of the mu opioid receptor designed with the goal of alleviating gastrointestinal side effects of opioid therapy without affecting analgesia. These positive clinical results support progression into Phase 3 development for the treatment of patients with opioid-induced constipation.
The Phase 2b program consists of three studies (0074, 0076 and 0084) designed to evaluate doses and dosing regimens for Phase 3. The key study in this program is 0084, a 5-week, randomized, double-blind, parallel-group, dose-ranging study evaluating 5 mg, 10 mg, and 15 mg doses of TD-1211 versus placebo. This study randomized 217 patients with OIC. During the 2-week baseline period, patients had on average
0.1 to 0.3 complete spontaneous bowel movements (CSBMs) per week. All patients randomized into a TD-1211 arm received 5 mg for the first four days of dosing. On Day 5, these patients either remained at 5 mg or were dose-escalated to 10 mg or 15 mg for the remainder of the 5-week treatment period. Patients randomized into the placebo arm received placebo for all five weeks.
The primary efficacy endpoint was the change from baseline in average CSBMs per week over the last four weeks of treatment for the three doses of TD-1211 and placebo in the Efficacy Analysis (EA) population.
Study 0084 achieved the primary efficacy endpoint for all doses of TD-1211.
Date: July 10, 2012
Source: Theravance Inc.
Filed Under: Drug Discovery