Titan Pharmaceuticals Announces Positive Results from Phase III Clinical Trial of Probuphine for the Treatment of Opioid Addiction

Titan Pharmaceuticals, Inc. (AMEX:TTP) today announced positive, statistically significant results from its randomized, double-blind, placebo controlled, multi-center Phase III clinical trial of Probuphine®. Probuphine is Titan’s novel, subcutaneous implant formulation designed using its ProNeura technology to deliver six months of buprenorphine. Buprenorphine is currently marketed as a sublingual formulation for the treatment of opioid addiction.

Probuphine showed a clinically and statistically significant difference over placebo in illicit opioid use over 16 weeks as measured by urine testing performed three times per week (p=0.0361) – this was the primary endpoint acceptable to the U.S. Food and Drug Administration (FDA). Additionally, Probuphine achieved statistical significance in the Phase III trial’s key secondary endpoint, the difference in illicit opioid use from weeks 17-24 (p=0.0004). Moreover, Probuphine treatment showed a statistically significant difference in illicit opioid use versus placebo over the full six-month (weeks 1-24) period (p=0.0117).

“We are extremely pleased by these positive results and the potential of Probuphine to be an important advance in the treatment of opioid addiction,” said Marc Rubin, M.D., President and CEO of Titan. “Even as buprenorphine, with estimated sales of half a billion dollars in worldwide sales, is fast becoming the gold standard for opioid addiction treatment, there are growing concerns about compliance with and abuse of the currently available treatment options and a critical need for safe, effective treatment options. These data show that our proprietary subcutaneous implant can safely deliver Probuphine over six months. We look forward to completing this development program and forging strategic alliances to commercialize Probuphine worldwide.”

Additional secondary efficacy analyses, including the mean percentage of urines negative for illicit opioids over treatment weeks 1-16, 17-24, and the complete six-month period also statistically favored Probuphine over placebo. Another important indicator of treatment effectiveness, patient retention, was approximately 66 percent for Probuphine compared to 31 percent for placebo. Probuphine was also well tolerated throughout the six-month trial.

“These data are very promising and I believe that the success of Probuphine should have a very significant impact on our ability to effectively treat opioid addiction,” said Walter Ling, M.D., Professor of Psychiatry and Director of the Integrated Substance Abuse Programs at the David Geffen School of Medicine at UCLA, and a principal investigator in this trial. “As a clinician, I am concerned by the growing problem of opioid addiction, especially prescription opioid abuse, and the challenge of effectively treating our patients with a safe, abuse-resistant and diversion-resistant treatment. These data could translate into a dramatic change in our treatment possibilities.”

Worldwide, it is estimated that there are 6 million opioid addicts. Approximately one-half of this potential patient population is addicted to illicit opioids, such as heroin, and the other half to prescription drugs, such as oxycontin, methadone, and codeine. Until recently, the only approved medication assisted therapies for opioid addiction had been available at only a limited number of authorized facilities in the U.S. As of 2000, U.S. physicians can be certified to prescribe less restricted opioid addiction medications in an office setting, which has greatly expanded patient access to opioid addiction pharmaceutical therapies. Despite these advances, this remains a highly underserved market with only about 750,000 people globally receiving medicinal treatment for opioid addiction.
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source: Business Wire