Today, Titan Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has confirmed a Pre-New Drug Application (Pre-NDA) meeting with the company regarding Probuphine™ to be held on October 25th, 2011. Probuphine is an innovative, subcutaneous implant formulation that delivers a steady, round-the-clock dose of buprenorphine over six months following a single treatment. Titan is developing this formulation for the treatment of opioid dependence.
At the Pre-NDA meeting, Titan will review all elements of the Probuphine development program and seek FDA input and guidance on the proposed content of a New Drug Application (NDA). In preparation for the meeting, Titan is required to submit to the FDA a comprehensive briefing document by mid-September that includes data from all the non-clinical and clinical studies and the chemistry, manufacturing and control processes and procedures for the manufacturing of this formulation.
The FDA has agreed to review the Probuphine NDA submission under its 505(b)(2) regulations and can reference data that are in the public domain as well as rely on the FDA’s prior review of safety or efficacy for the reference listed drug. Guidance provided by the FDA in 2005 as part of the Investigational New Drug (IND) application discussions included a requirement that efficacy of treatment with Probuphine be demonstrated in two adequately controlled studies, and that the safety database include the treatment of approximately 500 patients with Probuphine for six months and approximately 100 patients for one year.
Katherine L. Beebe, Ph.D., Executive Vice President and Chief Development Officer of Titan, remarked, “This is an important meeting with the FDA to review all of the information on Probuphine development, especially the robust Phase 3 clinical results of Probuphine in the treatment of opioid addiction. We also expect to discuss and reach agreement with the FDA on the content and data required for the NDA. We believe the strong positive results from the two controlled studies of Probuphine and the follow-on re-treatment studies demonstrate the potential effectiveness of the treatment for opioid addiction and the safety and tolerability of this product. We look forward to our meeting with the FDA and obtaining their guidance on the sufficiency of these data so that we can appropriately plan the timing of our NDA submission.”
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