Posted by Michael Wonder on 29 Oct 2017
Heron Therapeutics granted FDA fast track designation for HTX-011 to reduce post-operative pain and the need for opioid analgesics for 72 hours
26 October 2017 - Phase 3 studies for HTX-011 ongoing; NDA filing planned for 2018.
Heron Therapeutics announced today that the U.S. FDA has granted fast track designation to the Company’s investigational agent, HTX-011, for local administration into the surgical site to reduce postoperative pain and the need for opioid analgesics for 72 hours. Fast Track designation is a process designed to facilitate the development and expedite the review of new therapies to treat serious conditions with unmet medical needs by providing sponsors with the opportunity for frequent interactions with the FDA. Heron recently initiated the HTX-011 Phase 3 program and expects to file an NDA in 2018.
HTX-011 is the first and only long-acting, extended-release formulation of the anaesthetic bupivacaine designed to address both postoperative pain and inflammation in a single administration at the surgical site. HTX-011 leverages meloxicam in our proprietary polymer formulation to potentiate the local anaesthetic activity of bupivacaine over 72 hours. In Phase 2 clinical studies, HTX-011 has consistently demonstrated superiority over both placebo and bupivacaine, the current standard-of-care, in all surgical models evaluated and significantly reduced the need for opioids following surgery.
