Titan Pharmaceuticals, Inc. (OTCBB:TTNP) said that the company is making good progress with its Phase 3 Study Of Probuphine. The company completed enrollment of patients for its pivotal Phase 3 trial of Probuphine. The drug candidate will treat the patients who suffer from opioid dependence. The medication is categorized as an investigational subdermal plant. The trial is anticipated to end by July 2015. Once the trial is over, Titan will resubmit NDA to the FDA later in this year.
The process
Braeburn Pharmaceuticals is assigned the responsibility of the Phase 3 trial. Titan will serve as the key sponsor of Probuphine trial. As of now, the company has selected 178 patients for the key study. The enrollments have been randomized in twenty-one different centers. The enrollment process was easy as the screening failure was less in the process. Also, patients showed high interest towards the study. It hardly took four months to complete the enrollment process. Braeburn is expanding its drug portfolio for opioid dependence. The new association will result in additional $50 million of future royalties for the company.
The developments
Kate Glassman Beebe of Titan Pharmaceuticals said that management is encouraged with the progress of Phase 3 trial of Probuphine. The company will assist Braeburn Pharmaceuticals at every step to finish the trial effectively. The plan is expected to yield a controlled review of Probuphine. The study can be termed as a double-blind form and double-dummy design form of research.
Classification
The assessment will be carried out in two categories. The enrollment process covered those people who are stated as clinically stable. These patients are taking maintenance treatment of sublingual formulation which contains buprenorphine. Titan Pharmaceuticals, Inc. (OTCBB:TTNP) said that the duration of trial will be nearly six months. Probuphine has potential to deliver stable amount of buprenorphine during this period. It is an implantable alternative for opioid dependence.
