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Titan Pharmaceuticals Announces Journal of the American Medical Association Publication of Phase 3 Probuphine™ Data
Date:10/12/2010

nce: A Randomized Controlled Trial" will appear in the October 13, 2010 issue of JAMA and details key trial results:

  • Patients receiving Probuphine had a mean percentage of urine samples that tested negative for illicit opioids across the full 24 weeks of 36.6 percent; those in the placebo group had a mean of 22.4 percent (p=0.01)
  • Nearly 66 percent of patients receiving Probuphine completed the study vs. the 31 percent who received placebo implants (p<0.001)
  • Probuphine patients experienced fewer clinician-rated (p<0.001) and patient-rated (p=0.004) withdrawal symptoms
  • Probuphine patients reported lower ratings of craving (p<0.001)
  • Probuphine patients had a greater change on clinician global ratings of severity of opioid dependence (p<0.001)
  • Probuphine patients demonstrated a greater change on the clinician global ratings of improvement (p<0.001)
  • Minor implant site reactions were the most common adverse events and were consistent across the Probuphine and placebo groups

  • Titan is currently conducting a confirmatory Phase 3 clinical trial of Probuphine for the treatment of opioid addiction.  Patient enrollment in that trial is now complete and results are expected in the second quarter of 2011, approximately three months ahead of the original schedule.  This study is part of Titan's registration-directed program intended to obtain marketing approval of Probuphine for the treatment of opioid addiction in the U.S. and Europe.

    "We believe that Probuphine represents a significant step forward in the safe and effective treatment of opioid addiction," said Dr. Katherine L. Beebe, Senior Vice President, Clinical Development and Medical Affairs and a co-author of the publication.  "Probuphine was designed as an innovative implant formulation so that it could reduce the risk of diversion and abuse.  With only one treatment, Probuphine provides a round-the-clock
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    SOURCE Titan Pharmaceuticals, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

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