On November 20, 2014, Titan Pharmaceuticals, Inc. (OTCMKTS:TTNP) reported conclusion of enrollment in the Phase III clinical trial PRO-814 to support re-filing of the NDA for Probuphine. The enrollment of the trial was done in almost four months, two months ahead of company’s schedule. The trial is planned to address key issues that were asked by the U.S. FDA and its complete response letter back in 2013 after the assessment of the original NDA.
Titan’s PRO-814 clinical trial is a randomized, double dummy design, double blind, that is projected to enroll almost 180 patients into two different treatment arms. The subjects will be clinically stable patients who are getting maintenance treatment with an accepted sublingual formulation having buprenorphine administered daily (8 mg or less).
Patients under trial will be randomized to obtain either 4 Probuphine implants, or to stay with the daily sublingual buprenorphine treatment. It is in contrast to the previous NDA that asked for use of Probuphine in patients who are opioid addicts and are first starting with buprenorphine therapy. The patients will be administered for six months. The primary study will be a non-inferiority assessment of responders in the two different groups.
Titan’s PRO-814 clinical trial is expected to be completed by mid-2015, and results will be available as soon as June 2015. Braeburn is funding this trial, with Titan Pharmaceuticals, Inc. (OTCMKTS:TTNP) continuing to offer logistical support. In the quarter, the company continued to assist Braeburn in the CMC regulatory and clinical preparation activities of the Probuphine including the manufacturing tasks related with the assessment of the manufacturing process. If everything goes as planned, the company can resubmit NDA before the end of 2015. After the submission, the FDA will take another six months to respond to the application, putting a new PDUFA date in the first half of 2016.