Titan Pharma aims to carry Ph3 success to FDA meeting

Titan Pharmaceuticals might have some momentum going into its planned talks with U.S. regulators this fall. The South San Francisco-based developer is reporting positive results of a confirmatory Phase III trial of its lead drug for opioid dependence.

With opioid addiction raging, Titan's late-stage trial of its treatment Probuphine showed that the drug was superior to a placebo in staving off illicit use of opioids over a 24-week period and it met its goal of showing non-inferiority to the approved treatment Suboxone (which has the generic name buprenorphine). Further data from the trial will be revealed in the coming weeks and at a scientific meeting later this year.

For now, Titan can claim a victory for Probuphine, which releases buprenorphine through an implant over the course of 6 months to boost compliance among patients with opioid dependence. The treatment is the most advanced in the small company's pipeline, making its success key to the company's business.

"We are highly encouraged by these compelling findings, which confirm the positive results from our previously reported, placebo-controlled study, and believe that Probuphine represents an important medical advance in the effective treatment of patients suffering from opioid addiction," Katherine Beebe, Titan's chief development officer, said. "We look forward to continuing our ongoing dialogue with regulatory authorities to efficiently advance Probuphine toward approval and also to progressing discussions with potential commercialization business partners."

- here's Titan's release