Titan Pharmaceuticals, Inc. today announced that the United States Patent and Trademark Office (USPTO) has issued patent number 7,736,665 covering Probuphine for the treatment of opiate addiction. Titan is the assignee of this patent which claims a method for treating opiate addiction with a subcutaneously implanted device comprising buprenorphine and ethylene vinyl acetate, a biocompatible copolymer that releases buprenorphine continuously for extended periods of time. This patent, which also includes certain additional claims covering the composition and dimensions of the device, will expire in June 2023 excluding any patent term adjustment which is expected to add several months to the life of the patent.
Probuphine is designed to deliver six months of continuous, therapeutic levels of buprenorphine following a single treatment, and has the potential to reduce limitations currently associated with daily oral buprenorphine therapy, including poor compliance, variable blood levels contributing to opioid withdrawal and craving symptoms, and misdirection of drug. The safety and effectiveness of treatment with Probuphine has been initially established in the three Phase 3 studies conducted to date, and the Company is currently conducting a confirmatory Phase 3 clinical study in the U.S. which is partially funded through a two year $7.6 million NIH grant being administered by the National Institute on Drug Abuse (NIDA). This study is designed to confirm the safety and effectiveness of treatment with Probuphine versus placebo in reducing the use of illicit opioids over the 24 week treatment period, and also to perform a non-inferiority comparison of Probuphine with Suboxone® which is the widely used sublingual formulation of buprenorphine approved for the treatment of opiate addiction. This 250 patient three arm study is currently enrolling patients at 17 sites in the U.S. and is expected to complete enrollment by year end with results available in Q3 2011.
"We are very pleased by the issuance of this patent which is expected to provide exclusivity in the U.S. for Probuphine at least through mid 2023," said Sunil Bhonsle, President of Titan. "We are also highly encouraged by the rapid progress in the confirmatory Phase 3 study," he concluded.
"Issuance of this patent is a major milestone in support of the potential commercial value of Probuphine," said Marc Rubin, MD, Executive Chairman of Titan. "The board is very pleased with the progress and believes that Probuphine has the potential to provide an important new treatment option for patients with opiate addiction," he added.
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