Titan Pharma in general agreement with FDA on pathway for Probuphine

USA-based Titan Pharma (OTCBB: TTNP) and its partner, Braeburn Pharmaceuticals, have agreed in principle with the US Food and Drug Administration on the design of a clinical study in support of the New Drug Application for Probuphine (buprenorphine), the company’s investigational subdermal implant for the maintenance treatment of opioid dependence.

The proposed clinical study will be a randomized, double-blind and double-dummy design that will provide information for a non-inferiority comparison of a six-month treatment with a dose of four Probuphine implants to treatment with 8mg or less of an approved daily dosed sublingual formulation of buprenorphine. Details of the study, including size and the data analysis plan, will be established following the FDA’s review of a complete study protocol, which Braeburn expects to submit within the next two weeks.

“We are pleased that there is general agreement on the clinical study," said Kate Glassman-Beebe, executive vice president and chief development officer at Titan, adding: "This study design provides the best opportunity for an unbiased comparison of treatment with Probuphine to the current standard of care practice, while making sure all patients will receive active treatment for the disease."