ARTICLE | Clinical News

Titan's Probuphine meets Phase III endpoint

July 12, 2011 12:18 AM UTC

Titan Pharmaceuticals Inc. (OTCBB:TTNP) said Probuphine buprenorphine met the primary endpoint in a Phase III trial to treat opioid dependence. The product led to a significantly greater proportion of patients with opioid-negative urine samples as measured by the cumulative distribution function of negative urines over 24 weeks vs. placebo (p<0.0001). Probuphine also met the FDA-requested primary endpoint of a greater proportion of opioid-negative urine samples with incorporated patient self-reported opioid use over 24 weeks vs. placebo (p<0.0001). The double-blind, U.S trial enrolled 287 patients aged 18-60 with opioid dependence. ...