Titan Pharmaceuticals, Inc ,a company developing proprietary therapeutics for the treatment of select chronic diseases utilizing its ProNeura™ long-term, continuous drug delivery platform announced that the U.S. 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."
About Titan Pharmaceuticals
Titan Pharmaceuticals Inc. , based in South San Francisco, CA, is developing proprietary therapeutics primarily for the treatment of serious medical disorders. The company's lead product is Probuphine®, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Probuphine employs Titan's proprietary drug delivery system ProNeura™, which is capable of delivering sustained, consistent levels of medication for three months or longer. Titan has granted commercial rights in the U.S. and Canada for Probuphine to Braeburn Pharmaceuticals. Approved by the U.S. Food and Drug Administration in May 2016, Probuphine is 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. The ProNeura technology has the potential to be used in developing products for treating other chronic conditions such as Parkinson's disease and hypothyroidism, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.
Titan Pharmaceuticals, Inc.
Sunil Bhonsle, President and CEO