Heron Therapeutics preps NDA as its long-acting anesthetic sails through phase 3

Nearly one-third of bunionectomy patients and half of hernia repair patients receiving HTX-011 did not need opioids in the 72 hours after surgery. (Steve Buissinne)

Heron Therapeutics' long-acting local anesthetic met all of its primary endpoints and key secondary endpoints in a pair of phase 3 trials, setting it up for a new drug application in the second half of this year. 

HTX-011 is a long-acting formulation of the standard of care, bupivacaine solution, combined with the anti-inflammatory medication, meloxicam. 

"[It] is administered as a single-dose application via needle-free syringe to directly coat the affected tissue within the surgical site prior to suturing, which makes HTX-011’s route of administration faster, easier and potentially safer compared to numerous injections required with current local anesthetics," the company said in a statement.

The trials pitted the anesthetic, HTX-011, against placebo and bupivacaine in patients undergoing bunion-correcting surgery or hernia repair. The drug significantly reduced pain intensity—the primary endpoint—and also decreased opioid use for 72 hours after surgery in both trials, the company said. 

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The bunionectomy trial compared a 60 mg dose of HTX-011 to a 50 mg dose of bupivacaine and place to control post-operative pain in 412 patients. Patients treated with HTX-011 had a 27% decrease in pain intensity compared to those on placebo, and an 18% reduction compared to those taking bupivacaine. The HTX-011 group also took 37% less opioids than the placebo group and 25% less than the bupivacaine group during the 72 hours following surgery. And nearly a third (29%) of HTX-011 patients didn't need any opioids in the 72-hour window. 

As for the hernia repair patients, the treatment arm received 300 mg of HTX-011 compared to the standard 75 mg dose of bupivacaine. The HTX-011 group demonstrated a 23% and 21% drop in pain intensity compared to placebo and bupivacaine respectively. The 72-hour post-surgical opioid use closely mirrored the results for the bunionectomy trial, while half of the HTX-011 patients required no opioids in the 72 hours after surgery. 

HTX-011 could come in handy in the fight against the opioid crisis that rose as doctors became less judicious about prescribing the powerful painkillers. 

“We look forward to submitting a New Drug Application for HTX-011 to the U.S. Food and Drug Administration in the second half of 2018. If approved, we believe that HTX-011 could have a significant impact on the opioid crisis by reducing the use of opioids after surgery, while at the same time allowing patients to experience less pain," said Heron CEO Barry Quart.

"We currently assume peak sales of $545M driven by HTX-011’s differentiated profile and the fact that it should receive a superiority claim vs generic bupivacaine in its label for both bunionectomy and hernia surgery. Recall, Exparel [an injectable form of bupivacaine marketed by Pacira Pharma] does not have this claim in its label," wrote Jefferies analysts.