Titan Pharmaceuticals, a biopharmaceutical company, has reported that the US Patent and Trademark Office has issued new patent 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.
The safety and effectiveness of treatment with Probuphine has been initially established in the three Phase III studies conducted to date, and the company is currently conducting a confirmatory Phase III clinical study in the US which is partially funded through a two-year $7.6 million National Institutes of Health grant being administered by the National Institute on Drug Abuse.
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 US and is expected to complete enrollment by the end of 2010 with results available in the third quarter of 2011.
Sunil Bhonsle, president of Titan, said: „We are very pleased by the issuance of this patent which is expected to provide exclusivity in the US for Probuphine at least through mid-2023. We are also highly encouraged by the rapid progress in the confirmatory Phase III study.“