Heron Therapeutics said on Monday the U.S. Food and Drug Administration has once again declined to approve its non-opioid painkiller for post-operative pain and sought more data, sending its shares down 32% in early trading.
The drug developer said the agency did not identify any clinical or efficacy issue with the drug, but pointed out four non-clinical issues, including those relating to some additional ingredients of the treatment HTX-011.
Heron's treatment is a combination of the local anesthetic bupivacaine and a low dose of a nonsteroidal anti-inflammatory drug called meloxicam.
The company said the agency's response is not a barrier to approval as all the ingredients have been used in pharmaceuticals before.
The FDA has been pushing drugmakers to develop alternatives to opioid-based painkillers as the United States grapples with opioid addiction, with prescription opioids involved in 32% of all opioid overdose deaths in 2018, according to the Centers for Disease Control and Prevention.
One of Heron's biggest competitors for the non-opioid post-surgery painkiller is Pacira Biosciences Inc, whose long-acting Exparel is priced at $180.35 for a 10ml dose and $334.18 for the 20ml dose.
The FDA had previously declined Heron's application, citing issues relating to manufacturing at a contract drgumaker's site, among other things.
The company then resubmitted a new drug application in October last year and a new inspection of the site did not result in any issues.
Heron's treatment has earlier received FDA's fast track and breakthrough therapy designations.
(Reporting by Vishwadha Chander and Dania Nadeem in Bengaluru; Editing by Saumyadeb Chakrabarty and Arun Koyyur)
