Heron Wins Approval for Non-Opioid Drug, Allay Therapeutics Launches in Pain Management Space

Shares of Heron Therapeutics are climbing this morning after the company announced the U.S. Food and Drug Administration (FDA) approved its non-opioid drug for extended pain relief following some surgeries. The approval comes at a time when an opioid abuse epidemic still grips the country.

San Diego Heron’s Zynrelef (bupivacaine and meloxicam) is an extended-release dual-acting local anesthetic approved for use in adults for soft tissue or periarticular installation to produce postsurgical analgesia for up to 72 hours after a bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty. The FDA previously rejected Heron's asset in 2019.

When administered to patients, Zynrelef delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam. Patients in studies felt less pain and did not require the use of any opioids following surgery. That was in comparison to the use of standard-of-care bupivacaine solution, the company said.

During Phase III studies, Zynrelef provided superior, sustained postoperative pain relief for up to 72 hours and decreased the need for opioids. In its announcement, Heron said more patients who received Zynrelef were opioid-free compared to bupivacaine solution alone. 

Barry Quart, chairman and chief executive officer of Heron Therapeutics, said the approval is an “exciting milestone” in pain management. Not only can Zynrelef reduce postoperative pain for up to 72 hours, but Quart also said it had been shown to eliminate the need for opioid use among many patients following surgery. Since 1999, nearly 1 million people in the U.S. have died from an opioid-related overdose, according to the U.S. Centers for Disease Control and Prevention. 

Alan Rechter, an orthopedic surgeon at Orthopaedic Associates LLP, said there are approximately 50 million surgeries conducted in the United States each year. Of those, up to 67% of patients receive opioids to manage pain. 

“Through today's approval of Zynrelef, we now have a new therapy to offer patients, with the potential to meaningfully impact the postoperative pain management landscape and reduce, and even eliminate, unnecessary exposure to opioids in many patients,” Rechter said in a statement. 

While Heron celebrates its win, Allay Therapeutics, a new company specializing in non-opioid therapeutics, posted data showing its non-opioid medication continues to provide pain relief two weeks after administration. The data comes from a Phase Ib/IIa study of the company’s lead candidate, ATX-101, which is in development to treat pain after total knee replacement.

ATX-101 is a small dissolvable product candidate that incorporates bupivacaine. The therapeutic is designed to be used during surgery to deliver continual, localized pain relief that matches the pain trajectory patients typically experience after total knee arthroplasty (TKA) surgery. There are more than 1 million TKA surgeries performed each year in the U.S. The procedure is associated with a lengthy and painful recovery typically managed by opioid use.

Allay CEO Adam Gridley said innovation in pain management has been stalled for too long. He said new options are needed in the face of the opioid crisis and the increasing number of surgeries being performed. 

“Allay was founded to deliver a gentler longer-term recovery for patients and ease the burden of pain management and opioid use for the healthcare system. We believe these unprecedented clinical data could be the start of a new era of ultra-sustained pain management,” Gridley said in a statement.

The company’s focus is to initiate a Phase IIb study of ATX-101 and follow up on the data generated in the Phase Ib/IIa study. Allay said it intends to begin the study later this year and lay the groundwork for a Phase III study. 

In addition to ATX-101, Allay has also developed proof-of-concept of new implant variants, injectable formulations, formulations to permit patient self-dosing “on demand,” and formulations that incorporate various small molecules and other local analgesics.