Titan Pharmaceuticals, Inc. (OTCBB:TTNP) completed enrollment for its Phase 3 Study of Probuphine for patients with opioid dependence. It is investigational subdermal implant for the treatment of opioid dependence. The company expects Phase 3 Study to complete by mid-2015. It will pave way for resubmission of the NDA for Probuphine with the FDA later in this year.
Braeburn Pharmaceuticals is looking after the Phase 3 study of Probuphine. It is the sponsor of key study. It has selected 178 patients and randomized them across 21 centers. With a high patient interest and low screening failure, Braeburn completed enrollment in just four months. It expanded its portfolio for opioid dependence, adding up to approximately $50 million to Titan’s future royalties.
The management view
Kate Glassman Beebe, the CDO and Executive VP of Titan Pharmaceuticals, Inc. (OTCBB:TTNP), said that the company is delighted with the progress of Phase 3 Study of Probuphine. They will provide all the needed support to Braeburn to complete the study and resubmit the NDA. The study design is carefully planned, and it will result in a well-controlled evaluation of Probuphine.
The Phase 3 Study of Probuphine is a double-blind, randomized and double-dummy design research. The enrollment will evaluate patients in two treatment plans. The enrolled population consists of clinically stable patients. They are receiving maintenance treatment of sublingual formulation containing buprenorphine. They are given a daily dose of 8mg or less. The patients will be treated for approximately six months.
Behshad Sheldon, the CEO of Braeburn Pharmaceuticals said that the company is committed to develop a wide range of treatment of opioid dependence. Probuphine has a unique capability to deliver steady levels of buprenorphine for six months. Therefore, it is the only implantable alternative in Braeburn’s portfolio. It is an effective option for the long-term maintenance treatment for opioid dependence.