San Diego-based drug manufacturer Heron Therapeutics (HRTX
25.65, +1.90, +8.00%) sits higher on Monday after the FDA announced the
acceptance of the new drug application (NDA) for Heron's opioid-alternative
pain management investigational agent, HTX-011, and granted it a Priority
As a bit of background, Heron’s HTX-011, which is intended for the management and relief of postoperative pain, is a long-acting, extended-release formulation of local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory drug meloxicam. HTX-011 is the first and thus far only dual-action fixed-combination product specifically designed to address both postoperative pain and inflammation via a single administration at the surgical site.
First submitted on October 30, 2018, the NDA for HTX-011 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 indicated that it is not currently planning to hold an advisory committee meeting to discuss this application and set a Prescription Drug User Fee Act goal date of April 30, 2019.
The FDA had previously granted Breakthrough Therapy designation for HTX-011 based on the results of Phase 2 studies and two completed Phase 3 studies, which showed that HTX-011 produced significant reductions in both pain intensity and the need for opioids through 72 hours post-surgery compared to placebo and bupivacaine solution, which is the standard of care.
The FDA has now granted Priority Review designation to the NDA for HTX-011. Priority Review designation is for drugs that, if approved, would present significant improvements in the safety or effectiveness of the treatment or prevention of serious conditions. HTX-011 is the first and only non-opioid, long-acting local anesthetic to demonstrate in Phase 3 studies a statistically significant reduction in severe pain and an increase in the number of patients who require no opioids for 72 hours postoperatively versus bupivacaine solution.
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.
At one point this year shares of HRTX held a 137% advance, but broader market and industry stock declines have since trickled down to Heron. The stock’s gains on the year (+41%) still outpace the year's losses in the broader sector (IBB -10%) as investors place confidence in the company’s opioid-alternative candidate.
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