Third time’s the charm as Heron wins FDA nod for non-opioid anesthetic Zynrelef
With an aim to reduce the use of opioids in the post-op setting, Heron Therapeutics on Thursday announced that it finally won FDA approval — after two prior CRLs — for its long-lasting local anesthetic, which is a combination of bupivacaine and the NSAID meloxicam.
Heron will price the drug, known commercially as Zynrelef, somewhere between 22% and 28% less than its direct competitor, Pacira Biosciences’ Exparel (bupivacaine liposome injectable suspension), Heron CEO Barry Quart told Endpoints News in an interview.
“We’re not looking at how we’re priced versus the competitor. What we’re predominately interested in is at what price we can get maximum access to the product as hospitals are constrained,” Quart said.
That 22-28% discount could prove to be a major advantage for Zynrelef, according to Wall Street biotech analysts. Leerink expects peak sales for Zynrelef to be more than $500 million by 2025, and a recent survey from the bank in January showed how a 25% discount could increase the number of hospitals willing to use the drug.
Evercore ISI analysts noted Thursday a “somewhat (but not entirely)” surprising move by the FDA to limit the labelled indications for the approval to bunionectomy, open herniorrhaphy and total knee arthroplasty rather than granting a broader label. But the company notes there is a speedy path forward to further broaden the label to address more patients.
Zynrelef has been rejected twice by the FDA — first in May 2019, for manufacturing concerns, and then again last year for concerns related to quantifying the exposure to certain excipients used in the drug.
“It’s taken a while, but it’s definitely worth all the effort to get this important product out to patients,” Quart said. “The first CRL was predominately related to manufacturing questions and we provided the information the agency needed. Unfortunately, during the review [after the first CRL], the agency asked for some additional information related to excipients in the product. We basically got stuck right at a point where the FDA was making public their inactive ingredient database so they were very rigid about making sure they had all of the information on these inactive ingredients.”
Quart also said he anticipates relatively fast uptake of the drug as hospitals look to reduce their use of opioids, particularly after surgeries, when patients often use just a fraction of the opioids that they receive with a prescription. About 90,000 Americans died from opioid-related overdoses in 2020, which compares with about 70,000 in 2019.
For hospitals with experience with the product, Quart said he expects to see “rapid uptake,” but there’ll be a group of hospitals that take longer to determine whether or not to put Zynrelef on their formularies.
“We don’t really look at it in terms of market share for opioids,” he said. “What we look at is the need to reduce or eliminate the need for opioids. In our clinical studies in the package insert, you’ll see that we were able to eliminate the need for opioids in over 50% patients having a hernia procedure, and about 30% of patients having a bunionectomy, which is a very painful procedure.”