Titan Pharmaceuticals Inc (TTNP)

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Titan Pharmaceuticals Announces First Patient Enrollment in Clinical Study of Probuphine for Opioid Dependence

Study Completion Expected in Mid-2015 Followed by Potential Resubmission of Probuphine New Drug Application

Titan Pharmaceuticals, Inc.
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SOUTH SAN FRANCISCO, CA--(Marketwired - Jul 21, 2014) - Titan Pharmaceuticals, Inc. (OTCBB: TTNP) today announced enrollment of the first patients in the Phase 3 clinical study to support resubmission of the New Drug Application (NDA) for Probuphine®, the company's investigational subdermal implant for the maintenance treatment of opioid dependence. The study, which is expected to be completed by the middle of 2015, is designed to address key questions posed by the U.S. Food and Drug Administration (FDA) in its complete response letter last year after review of the original NDA. Titan's partner Braeburn Pharmaceuticals is sponsoring the trial and anticipates resubmission of the NDA to the FDA in late 2015.

"With more than 2 million people in the U.S. suffering from opioid dependence, there is a strong need for new treatments. If approved, Probuphine would be the first and only commercialized treatment of opioid dependence to provide continuous, around-the-clock blood levels of buprenorphine for six months following a single procedure," said Kate Glassman-Beebe, PhD., Titan's executive vice president and chief development officer.

Investigator training was conducted by Braeburn in June to review clinical study procedures, including special training for implant insertion and removal. Fifteen sites have obtained Institutional Review Board (IRB) approval, and Braeburn expects an additional six sites to be operational within the next few weeks. Fourteen sites are currently screening patients for randomization into the study and five patients have already been enrolled.

"We believe the fast pace with which a number of sites received IRB approval following our recent investigator training indicates the addiction community's support and need for novel treatments like Probuphine. Braeburn is committed to continue working with our clinical investigators to identify appropriate study patients and expedite enrollment in this study," said Behshad Sheldon, president and CEO of Braeburn Pharmaceuticals.

The clinical study is a randomized, double-blind, double-dummy design that is expected to enroll approximately 180 patients into two parallel treatment arms. The study population is clinically stable patients who are receiving maintenance treatment with an FDA-approved sublingual formulation containing buprenorphine at a daily dose of 8mg or less. Patients are being randomized to either receive four Probuphine implants, or to continue the daily sublingual buprenorphine therapy. To enable the double-blind design, those receiving Probuphine implants are required to take daily placebo sublingual pills, while those continuing on their stable dose of sublingual buprenorphine pills are required to be treated with four placebo implants. The patients are expected to be treated for six months, and the primary analysis will be a non-inferiority comparison of responders in the two arms.

Probuphine is designed to deliver continuous, around the clock blood levels of buprenorphine for six months following a single insertion procedure, and to simplify patient compliance and improve retention. It was developed using ProNeura™, Titan's continuous drug delivery system. Titan also has in development a ProNeura technology-based product for the treatment of Parkinson's disease and the company anticipates filing an investigational new drug application for that program in 2015.



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