Shares in QRxPharma (QRX) have plummeted 80% in early trade after the Food and Drug Administration in the US failed to approve its pain drug, Moxduo.
At 11.20am (AEDT) QRxPharma shares were 79.29% lower at 14.5 cents, against a benchmark index lift of 0.67%. In earlier trade, QRxPharma shares hit as low as 10.5 cents.
The FDA Anesthetic and Analgesic Drug Products Advisory Committee voted against approval of Moxduo, an immediate release dual opioid for the treatment of moderate to severe acute pain. The advisory committee found QRxPharma did not provide sufficient evidence to warrant approval of the drug at this time.
"We are obviously disappointed in the outcome of today's meeting, but remain confident in the advantages of Moxduo compared to morphine and oxycodone," QRxPharma chief executive officer John Holaday said.
"This is a necessary therapy for patients with moderate to severe acute pain.
"We are committed to bringing to market safer therapies for pain, such as Moxduo, and preventing opioid abuse."