Titan Pharmaceuticals Inc (TTNP)

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Titan Pharmaceuticals Receives FDA Communication On Ropinirole Implant Investigational New Drug Application

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February 27, 2017

SOUTH SAN FRANCISCO, Calif., Feb. 27, 2017 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ: TTNP), a company developing proprietary therapeutics for the treatment of select chronic diseases utilizing its ProNeura™ long-term, continuous drug delivery platform, today announced that the U.S. Food & Drug Administration (FDA) has completed its initial review of the ropinirole implant Investigational New Drug Application (IND) and has requested that Titan hold the initiation of the clinical study pending submission of the requested information and the agency's 30-day review.



In a telephone communication with Titan, the FDA indicated that it will require final release test data on the ropinirole implant and the applicator used to insert the implant before clearing the IND. Additionally, the FDA is requesting that Titan identify a participating Principal Investigator for the study. Titan expects to have final test data on the implant and the applicator within the next several weeks, and is in the process of qualifying the participating clinical sites. The FDA informed Titan that its written comments on the IND will be sent within the next 30 days.

"We understand the FDA's diligence and respect its request for additional information," said Titan Executive Vice President and Chief Development Officer Kate Beebe, Ph.D. "We are working quickly to provide the FDA with the additional information required, and are hopeful that we will be able to commence the clinical study toward the end of the second quarter."




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