Probuphine buprenorphine regulatory update

Titan received a complete response letter from FDA for an NDA for Probuphine buprenorphine to treat opioid dependence. According to the company, the agency requested additional data to support Probuphine's efficacy, including the effects of higher doses of Probuphine. The agency also requested human factors testing of the surgical implantation and removal procedures training for the product, a subcutaneous rod implant for continuous 6-month delivery of buprenorphine using Titan's ProNeura technology. Titan said it will discuss next steps with FDA. ...