The company’s HTX-011 product is a long-acting formulation of bupivacaine in combination with the anti-inflammatory meloxicam. Heron touts the product as the first dual-action, fixed-combination drug designed to address postoperative pain and inflammation in a single administration.
The FDA is set to make a decision about whether or not to approve HTX-011 by April 30. The agency reportedly indicated that it won’t hold an advisory committee meeting to review the application.
“We are pleased to receive Priority Review designation for the HTX-011 NDA,” CEO Barry Quart said in prepared remarks. “We believe that HTX-011 could have a considerable impact on the lives of patients by significantly reducing the proportion of patients who experience severe pain and receive opioids after surgery, especially at discharge.”
Previously, the FDA granted breakthrough therapy status for Heron’s HTX-011 product. HRTX shares were trading at $24.76 apiece today in mid-morning activity, up 4.2%.