APF530 regulatory update

FDA issued a complete response letter for an NDA from A.P. Pharma for APF530 to prevent chemotherapy-induced nausea and vomiting (CINV). According to the company, FDA did not request additional clinical efficacy studies, but did ask the company to conduct bioavailability, metabolism and QT studies in volunteers, as well as a re-analysis of selected existing Phase III data. FDA also expressed concerns about APF530's two-syringe administration system, including potential issues with the transfer of material between syringes prior to patient administration. Additionally, the letter identified deficiencies observed during an FDA inspection of the company's contract manufacturing facilities and requested clarification and revision of analytical specifications in the NDA. A.P. Pharma said some of the issues have been addressed in recent NDA amendments that FDA did not review prior to the complete response letter. The company plans to meet with FDA to discuss the letter, but does not expect to launch APF530 this year. ...