- Heron Therapeutics on Thursday said it won Food and Drug Administration approval for a post-operative painkiller that the San Diego-based company claims can help keep patients off opioids.
- The extended-release drug, which will be sold as Zynrelef, combines a generic and widely used anesthetic called bupivacaine with a low dose of the anti-inflammatory medicine meloxicam. The FDA cleared Zynrelef to treat pain in patients for as long as 72 hours after a bunionectomy, hernia repair or knee replacement surgery.
- The green light from the FDA comes after two misstarts in 2019 and 2020, when the agency withheld approval of the medication and asked Heron for more information on manufacturing and other non-clinical issues.
Heron plans to position Zynrelef as a tool in the medical response to opioid addiction, which claimed the lives of almost 500,000 people in the U.S. between 1999 and 2019. Studies show that about two-thirds of the more than 50 million people who undergo surgery each year in the U.S. currently receive opioids, according to the company.
Zynrelef is targeted at a critical three-day window after surgery in which patients are most likely to need strong painkillers. Heron's research showed patients receiving the drug had significantly less pain and less need of opioids than those receiving a solution of bupivacaine alone.
Those studies may help Zynrelef compete with Exparel, a long-acting liposomal formulation of bupivacaine that is also marketed as an opioid alternative. Sold by Pacira BioSciences, Exparel brought in $413 million in sales last year, even as the COVID-19 pandemic slowed the elective surgery market.
Heron says Zynrelef offers significant value to patients and is pricing its option competitively. The wholesale acquisition cost for a 400mg/12mg dose will be $267.50, compared with $344.20 for a 266mg dose of Exparel, according a Heron presentation.
For Heron, the drug is important for its future growth. The company reported just $20 million in net product sales in the first quarter of this year and a net loss of $52.6 million, equivalent to 58 cents a share.
The San Diego-based biotech's pricing will help ensure broad access to Zynrelef and a strong launch, Heron CEO and Chairman Barry Quart said in a statement. Heron expects the drug to be fully available by July.
Shares in the company rose by as much as 5% in early Thursday trading, before paring back those gains. Pacira stock, by comparison, was trading down 1% by mid-morning.