- Shares in Heron Therapeutics Inc. soared about 30% higher in value Monday, boosted by news the company's experimental non-opioid treatment succeeded in two late-stage studies testing the drug for postoperative pain control.
- Results from the Phase 3 trials showed HTX-011 significantly reduced pain intensity and total opioid consumption through 72 hours following bunionectomy or hernia repair. Both studies pitted HTX-011 against placebo and a solution of the local anesthetic bupivacaine.
- Heron plans to file HTX-011 for U.S. approval in the second half of the year, seeking a broad label to cover postoperative use for a full 72 hours.
Local anesthetics like bupivacaine have long been used preceding surgery but are less frequently used following an operation due to a shorter duration of effect.
Currently the only long-acting local anesthetic approved for postoperative use is Pacira Inc.'s Exparel, which consists of a liposomal formulation of bupivacaine. Sales of Exparel totaled $280 million last year, but analysts believe the market has substantial room to grow — particularly given the scrutiny on prescribing opioids following surgery.
That's an element that Heron believes makes HTX-011 a more attractive option, and the company designed its studies to test the drug's effect on patient use of opioids.
"Acute use of opioid pain medications for postoperative pain control is directly linked to over 2 million new persistent opioid users every year and up to 440,000 new cases of Opioid Use Disorder annually, making postoperative opioid use an important contributor to the opioid epidemic in the United States," said Eugene Viscusi, a professor of anesthesiology and chief of pain medicine in the Department of Anesthesiology at the Sidney Kimmel Medical College, in a statement released by Heron.
Heron's HTX-011 combines an extended-release formulation of bupivacaine with the anti-inflammatory drug meloxicam.
Data from the first Phase 3 study, in patients undergoing bunionectomy, showed administration of HTX-011 reduced pain intensity by 27% and 18% versus placebo and bupivacaine, respectively. Notably, nearly 30% of patients who received HTX-011 required no opioid treatment for 72 hours following surgery, compared to 2% of those on placebo and 11% administered bupivacaine solution.
Results from the trial in hernia repair showed similar efficacy, with a 23% and 21% reduction in pain intensity compared to placebo and bupivacaine. Fully half of hernia repair patients on HTX-011 required no opioid intervention for 72 hours, versus 22% on placebo and 40% on bupivacaine.
In both studies, HTX-011's effectiveness versus placebo and bupivacaine was most notable through 24 hours, typically when patients experience the most intense pain.
No serious adverse events related to drug were reported and no patients discontinued treatment with HTX-011. Overall, a similar percentage of roughly eight in 10 patients in each cohort experienced some adverse event, most commonly dizziness and nausea.
Cowen analysts believe that a long-acting local anesthetic could eventually become a blockbuster product, but cost will be an issue. Bupivacaine as a solution is generic and costs far less than Exparel's branded liposomal formulation.
HTX-011's demonstration of efficacy over generic bupivacaine could be a key differentiator to spur uptake — Exparel's label, by comparison, only highlights its efficacy compared to placebo.
Heron stock briefly traded above $32 per share, a spike of roughly 50%, before paring back some of those gains to trade up 28% Monday morning. Shares in Pacira, its would-be rival in the postoperative long-acting anesthetic space, fell by 6%.