Heron's Non-Opioid, Post-Operative Pain Drug Approved By FDA: Why This Is Important

Shares of Heron Therapeutics Inc HRTX are higher after a long wait to get regulatory approval for its non-opioid pain drug.

What Happened: San Diego, California-based Heron, a commercial-stage biotechnology company focused on developing treatments for unmet patient needs, said Thursday the FDA has given its nod for its Zynrelef, codenamed previously as HTX-011, for use in adults as an extended-release dual-acting local anesthetic.

It is recommended for use in adults for soft tissue or periarticular instillation to produce post-surgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.

Zynrelef, according to the company, delivers a fixed-dose combination of local anesthetic bupivacaine, which is the current standard-of-care, and a low dose of non-steroidal anti-inflammatory drug, meloxicam.

The synergy between bupivacaine and meloxicam in Zynrelef has resulted in patients experiencing significantly less pain, including severe pain, and significantly more patients requiring no opioids after surgery.

Related Link: The Week Ahead In Biotech (May 9-15): Heron, Apellis FDA Decisions, Presentations and Earnings

Why It's Important: About 50 million Americans undergo surgery annually, and up to 67 percent of those patients receive opioids, Heron said, citing an orthopedic surgeon. With Zynrelef, surgeons now have an option to reduce, even eliminate, unnecessary exposure to opioids in many patients.

Heron has had a tough time getting the drug across the finish line.

The new drug application for the drug was originally submitted in October 2018. In response to the application, the FDA issued a complete response letter in April 2019, citing the need for additional CMC and non-clinical information.

Heron resubmitted the NDA in October 2019 and in February 2020 the company said the FDA extended the review period by three months, rendering the PDUFA data on June 26. A second complete response letter was handed out on June 29, with the FDA seeking additional non-clinical information.

Related Link: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates

The company went on to file a resubmission on Nov. 12.

"Our existing commercial team will immediately begin working with current accounts to gain formulary access, with full commercial availability expected by July 2021," said Heron CEO Barry Quart.

Ahead of the approval, Needham analyst Serge Belanger said he believes HTX-011 has the potential to play an important role, alongside Pacira Biosciences Inc.'s PCRX Exparel, in the large and expanding post-op pain management market.

Pacira reported Exparel sales of $114.7 million in the first quarter.

Needham has a Buy rating and a $28 price target for Heron shares.

HRTX/PCRX Price Actions: Heron shares were up 1.09% to $17.60, while Pacira had slipped 1.49% to 0.92 cents Thursday morning at publication.

Related Link: What are the top healthcare stocks to watch right now? Benzinga Global Small-Cap Conference streaming LIVE TODAY to find out.

(Photo by ThisisEngineering RAEng on Unsplash)