May 13, 2021

The U.S. FDA has approved Heron Therapeutics’ Zynrelef™ (bupivacaine/meloxicam) extended-release solution for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, or total knee arthroplasty in adults. Zynrelef is the first and only FDA-approved extended-release DALA (dual-acting local anesthetic).

Patients who undergo surgery tend to experience the most severe pain during the first 72 hours following their procedure. Up to 67% of surgery patients receive opioids to help manage post-operative pain, but this carries a risk of addiction and overdose. Zynrelef’s approval offers a potentially opioid-free pain management option for patients who undergo surgery to remove bunions (bunionectomy), repair hernias (open inguinal herniorrhaphy), or receive a total knee replacement (total knee arthroplasty).

In clinical studies, Zynrelef demonstrated superior, sustained postoperative pain relief for up to 72 hours and decreased the need for opioids compared to treatment with bupivacaine solution (a current standard of care). Zynrelef delivers a fixed-dose combination of the FDA-approved medications bupivacaine, a local anesthetic, and meloxicam, a nonsteroidal anti-inflammatory drug (NSAID).

Under the recommended dosing, Zynrelef should be applied one time only via topical administration prior to suturing. The total recommended dose varies based on the type of surgery: up to 2.3mL for bunionectomy, up to 10.5mL for open inguinal herniorrhaphy, and up to 14mL for total knee arthroplasty. Additional use of local anesthetics should be avoided for at least 96 hours following administration of Zynrelef due to the potential for additive toxic effects.

A black box warning cautions that NSAIDs can increase the risk of serious and potentially fatal cardiovascular thrombotic events, including heart attack and stroke, as well as the risk of serious and potentially fatal gastrointestinal adverse events such as bleeding, ulceration, and perforation of the stomach or intestines.

Heron Therapeutics has launched Zynrelef at a wholesale acquisition cost (WAC) of $267.50 per vial.

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