Heron Therapeutics Soars on Positive Phase III Results

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Heron Therapeutics said its late-stage anesthetic used to treat bunionectomy and hernia repair hit all primary and key secondary endpoints in two Phase III trials that cut down on the requirement of opioid drugs to treat pain – a significant point as the nation is in the grip of an opioid epidemic.

The news sent shares of Heron soaring more than 28 percent this morning. Shares of Heron his a morning high of $29.50 per share, but have slipped back to $27.55 as of 10:54 a.m. The stock closed at $21.58 on March 16.

This morning Heron said HTX-011 demonstrated statistically significant reductions in both pain intensity and the use of opioid rescue medications through 72 hours following surgery in patients who have undergone bunionectomy and hernia repair. The company said its HTX-011 treatment is the “first and only” long-acting local anesthetic to demonstrate significantly reduced pain and opioid use through 72 hours in a Phase III study compared to current post-operative standard of care, bupivacaine solution. HTX-011 is administered as a single-dose application via needle-free syringe to directly coat the affected tissue within the surgical site prior to suturing.

Barry D. Quart, chief executive officer of Heron, said HTX-011 is the only locally administered anesthetic that has demonstrated superior pain relief and a reduction in opioid use compared to the standard-of-care treatment. The company intends to seek approval from the U.S. Food and Drug Administration later this year.

“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,” Quart said in a statement.

The primary and key secondary endpoints for both Phase III studies were identical. The primary endpoint was pain intensity as measured by the Area Under the Curve (AUC) score from 0 to 72 hours post-surgery (AUC 0-72) compared to placebo. Secondary endpoints included comparison of AUC 0-72 of pain intensity to bupivacaine solution; the total amount of opioid rescue medication consumption compared to placebo through 72 hours after surgery; the proportion of patients who received no opioid rescue medication after surgery compared to bupivacaine solution; and the total opioid consumption through 72 hours after surgery compared to bupivacaine.

For patients who underwent bunionectomy treatment with HTX-011 resulted in a 27 percent reduction in pain intensity compared to placebo. There was also an 18 percent pain reduction when the Heron treatment was compared to standard-of-care. A key data point that is sure to please prescribers was that patients who received HTX-011 used 37 percent fewer opioids than placebo patients and 25 percent less than those who took the bupivacaine solution in the 72 hours following surgery. Additionally, data showed that 29 percent of the 412 patients who received HTX-011 required no opioid medication for 72 hours post-surgery compared to only 2 percent receiving placebo and 11 percent receiving the standard-of-care, bupivacaine solution, the company said.

Results were similar in the hernia repair study. Heron said its medication resulted in a 23 percent reduction in pain intensity compared to placebo. When compared to standard-of-care there was a 21 percent reduction in pain. When looking at a reduction of the use of opioids, in the 72 hours following the procedure HTX-011 patients required 38 percent less opioids than placebo patient and 25 percent less opioids than patients receiving bupivacaine solution. Remarkably, 51 percent of HTX-011 patients required no opioids in that 72-hour period.

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