Titan Pharmaceuticals, Inc (Pink Sheets:TTNP) today announced that the National Institutes of Health (NIH) has awarded a Research and Research Infrastructure Grand Opportunities grant to the company through the American Reinvestment and Recovery Act of 2009 (ARRA). The two year grant for Probuphine clinical development is expected to provide approximately $7.6 million, with the first year award of approximately $ 5.6 million now made available to Titan by the NIH. This grant will be administered by the National Institute on Drug Abuse (NIDA). These funds will directly support a substantial part of the second Phase 3 clinical study to confirm the safety and efficacy of Probuphine for the treatment of opioid addiction. Probuphine is an innovative, long-term, implantable formulation of buprenorphine that is designed to provide a constant, low level of drug for six months following a single treatment. It has the potential to address the key issues of treatment non-compliance and illicit diversion often reported with the currently available sublingual pill formulation.
Probuphine has been shown to be safe and effective in the three Phase 3 studies that have been completed to date, specifically:
- A six-month, double-blind, placebo-controlled safety and efficacy trial,
- A six-month, open-label re-treatment safety trial, and
- A pharmacokinetic safety study.
Data from these studies have been presented at the International Society of Addiction Medicine 2008 Annual Meeting in Cape Town, South Africa, and the American Society of Addiction Medicine 2009 Annual Meeting in New Orleans, LA.
“Seeking new and better medications for treating addiction is an important part of NIDA’s mission,” says Dr. Nora Volkow, NIDA director. “If successful, this study will broaden the options for treating opioid dependence and give physicians and their patients meaningful information on comparative risks and benefits.”