The experimental drug Moxduo shouldn’t be approved and doesn’t provide enhanced safety compared with the opioids alone, a Food and Drug Administration advisory panel voted unanimously. QRxPharma fell 80 percent to A$0.14 at the close of trading in Sydney, its largest drop since it began trading May 25, 2007.
Moxduo would have been QRxPharma’s first product on the market and also the first combination pill with two opioids if approved. The new drug is meant to treat moderate to severe pain, a $2.6 billion segment of the $8 billion spent annually on prescription opioids in the U.S., according to Sydney-based QRxPharma.
“We are obviously disappointed in the outcome of today’s meeting,” said John Holaday, QRXPharma’s chief executive officer, in a statement. “We are committed to bringing to market safer therapies for pain, such as Moxduo, and preventing opioid abuse.”
The painkiller didn’t provide a safety benefit, FDA staff members who reviewed QRxPharma’s application to sell the drug said in a report. The agency has twice rejected Moxduo, most recently in August. Panel members said QRxPharma’s data was inadequate so they couldn’t determine whether the drug was safer.
The drug is immediate release as opposed to extended release, a longer-acting class the FDA has focused risk management efforts on. The FDA encouraged doctors and patients in September to consider alternative treatments before using extended-release opioids in an attempt to curb abuse.
The longer-acting pills contain “much more” opioid than the faster-acting pills, the FDA said.
“Improper use of any opioid can result in serious side effects, including overdose and death, and this risk is magnified with” extended-release opioids, according to the FDA.
Drugmakers have been attempting to make tamper-resistant painkillers that would prevent crushing and dissolving the pills to snort or inject, though the FDA approved Zogenix Inc.’s Zohydro extended-release pure hydrocodone pill without qualities to prevent abuse in October. The FDA deemed Purdue Pharma LP’s new version of extended-release OxyContin tamper-resistant a year ago.
Combination products require companies to show the drug provides a benefit over the individual medicines. The FDA is expected to decide whether to approve Moxduo by May 25.
QRxPharma says Moxduo decreases the risk patients’ breathing will slow, a cause of death from opioid overdose. The company hopes to gain market share based on liver concerns with AbbVie Inc.’s Vicodin and generics, which combine hydrocodone and acetaminophen.
Hydrocodone is the most frequently prescribed opioid in the U.S., according to the Drug Enforcement Administration. The DEA proposed increased prescribing restrictions in February for hydrocodone products that would match morphine and oxycodone.
To contact the editors responsible for this story: Reg Gale at email@example.com Anjali Cordeiro, Lena Lee