Posted by Michael Wonder on 01 Jan 2019
FDA grants priority review designation for Heron Therapeutics' NDA for HTX-011, a non-opioid for post-operative pain management
31 December 2018 - FDA not currently planning advisory Committee Meeting for NDA.
Heron Therapeutics today announced that the U.S. FDA has accepted the new drug application for Heron's investigational agent, HTX-011, and has granted it a priority review designation. HTX-011 is a long-acting, extended-release formulation of the local anaesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of post-operative pain.
The application for HTX-011, which was submitted on October 30, 2018, comprises data from five Phase 2 clinical trials and two Phase 3 clinical trials that included over 1,000 patients undergoing five different surgical procedures. The FDA set a Prescription Drug User Fee Act goal date of 30 April 2019.
