FDA gives HTX 011 priority review in filing for post-operative pain.- Heron Therapeutics.

Heron Therapeutics announced that the FDA has accepted the new drug application (NDA) for Heron's investigational agent, HTX 011 (bupivacaine + meloxicam extended release) in post-operative pain, and has granted it a Priority Review designation. The NDA for HTX 011, which was submitted on October 30, 2018, comprises data from five Phase II clinical trials and two Phase III clinical trials that included over 1,000 patients undergoing five different surgical procedures.

The overall safety profile of HTX 011, administered locally into the surgical site without a needle, was similar to that of the well-established safety profile of bupivacaine solution, without evidence of meloxicam-related toxicities. The FDA also indicated that it is not currently planning to hold an advisory committee meeting to discuss this application. The FDA set a Prescription Drug User Fee Act goal date of April 30, 2019.

Comment: HTX 011 is a long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. HTX 011 is the first and only dual-action fixed-combination product specifically designed to address both postoperative pain and inflammation in a single administration at the surgical site.