Titan Pharmaceuticals, Inc.(OTCBB:TTNP) updated on the progress of its Phase 3 Study Of Probuphine. It had completed enrollment of patients in its Phase 3 trial of Probuphine. The medication is aimed to treat the patients with opioid dependence. It is classified as an investigational subdermal plant. The phase 3 trial is expected to complete by July 2015. After the completion of Phase 3, the company will resubmit NDA for Probuphine for FDA approval later in this year.
The Phase 3 trial of Probuphine will be guided by Braeburn Pharmaceuticals. Titan Pharmaceuticals, Inc.(OTCBB:TTNP) will act as the sponsor of the study. Titan Pharmaceuticals has finalized 178 patients for the Phase 3 study. The patients have been randomized across 21 centers. The company didn’t face any problem in enrollment due to low screening failure and high patient interest towards the study. The enrollment process was completed in just four months. Braeburn also expanded portfolio for opioid dependence, resulting in additional $50 million future royalties for Titan Pharmaceuticals.
Kate Glassman Beebe, the Executive VP of Titan Pharmaceuticals, Inc.(OTCBB:TTNP) commented that management is pleased with the development of Phase 3 trial of Probuphine. Titan Pharmaceuticals will assist Braeburn at every step to complete the study successfully. The study plan is expected to result in a controlled assessment of Probuphine.
The Phase 3 trial of Probuphine is a randomized, double-dummy design and double-blind form of research. The evaluation will be done in two categories. Braeburn has enrolled those people who are confirmed as clinically stable. They are taking long-term maintenance medication of sublingual formulation containing buprenorphine. The duration of Phase 3 trial will be approximately six months. Braeburn Pharmaceuticals said that Probuphine has capability to deliver steady amount of buprenorphine for six months. It is a type of implantable alternative for opioid dependence in its product portfolio.