Titan Pharmaceuticals Presents Phase 3 Probuphine™ Data at Society for Neuroscience Annual Meeting
SOUTH SAN FRANCISCO, Calif., Nov. 17, 2010 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (OTC Bulletin Board: TTNP) today announced that data from its Phase 3 clinical development program for Probuphine were presented at the Society for Neuroscience Annual Meeting, being held Nov. 13-17 in San Diego. The presentation, "Development of an Implantable Formulation of Buprenorphine for Opioid Addiction," was delivered by Katherine Beebe, Ph.D., senior vice president, clinical development and medical affairs at Titan and outlined the positive data demonstrated by Probuphine in Phase 3 clinical trials conducted to date in patients with opioid addiction. These trials include a six-month randomized, placebo-controlled study and a six-month, open-label retreatment study.
Probuphine is an innovative, subcutaneous implant formulation designed using Titan's proprietary ProNeura™ technology to deliver a steady, round-the-clock low dose of the marketed drug buprenorphine over six months following a single treatment.
"We continue to be extremely encouraged and excited by these compelling Probuphine data," stated Dr. Beebe. "Our findings show that Probuphine - which with only one treatment can provide a round-the-clock, effective low dose of buprenorphine over six months - has been effective in significantly decreasing illicit opioid use. We look forward to completing our currently ongoing Phase 3 confirmatory study early next year, and, potentially providing patients suffering from opioid addiction with a novel, safe and effective treatment."
Data from Titan's completed Phase 3 randomized, placebo-controlled clinical trial of Probuphine in patients with opioid addiction were also recently published in the Journal of the American Medical Association (JAMA) October 13, 2010 issue. That article highlighted data from the 163-patient trial, which showed that patients receiving Titan's Probuphine implant had significantly less illicit opioid use, experienced fewer symptoms of withdrawal and craving, stayed in treatment longer and had greater overall improvement when compared to placebo patients over the course of the six-month study.
Titan's ongoing Phase 3 confirmatory clinical trial of Probuphine for the treatment of opioid addiction is 50% funded by a grant from the National Institutes of Health (NIH) and the National Institute on Drug Abuse (NIDA). 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.
Probuphine is designed to deliver six months of continuous round-the-clock, long-term therapeutic levels of the drug buprenorphine following a single subcutaneous treatment. Buprenorphine, an approved agent for the treatment of opioid addiction, is currently available mainly in the form of a sublingual tablet formulation. The safety and effectiveness of treatment with Probuphine has been initially established in the clinical studies that are part of the ongoing Phase 3 program, specifically, a 163-patient placebo-controlled study which demonstrated clinically meaningful and statistically significant treatment with Probuphine over a six-month period, an open label six-month retreatment study in 62 patients who had successfully completed six months of treatment in the controlled study, and a relative bioavailability study in nine patients treated with Suboxone® and then switched to Probuphine treatment for 60 days.
Probuphine was developed using ProNeura, Titan's continuous drug delivery system that consists of a small, solid rod made from a mixture of ethylene-vinyl acetate (EVA) and a drug substance. The resulting product is a solid matrix that is placed subcutaneously, normally in the upper arm in a simple office procedure, and is removed in a similar manner at the end of the treatment period. The drug substance is released slowly, at continuous levels, through the process of diffusion. This results in a constant rate of release similar to intravenous administration.
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SOURCE Titan Pharmaceuticals
Released November 17, 2010