Shares of Titan Pharmaceuticals Inc., a biopharmaceutical company engaged in the development of proprietary therapeutics mainly for the treatment of central nervous system disorders, jumped in today’s trading after the company provided an update on its Probuphine™.
Titan Pharmaceuticals said that it met with the U.S. FDA for a Pre-New Drug Application (Pre-NDA) meeting relating to Probuphone, which is an innovative subcutaneous implant formulation of buprenorphine. Following the meeting with the FDA, the company believes that its phase III clinical program completed to date is acceptable to the agency to support submission of a NDA through the 505(b)(2) pathway. The company also believes that the FDA does not require any additional clinical efficacy or safety studies for the drug.
Sunil Bhonsle, president of Titan Pharmaceuticals, said that the company is extremely pleased with the preliminary outcome as it believes it allows it to move forward rapidly and efficiently with its ongoing partnership discussions for Probuphine.
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