QRxPharma faces third FDA knockback for Moxduo

Shares in QRxPharma (ASX:QRX) sank 80% on Wednesday after the company revealed that it’s facing another regulatory knockback in the US for its dual-opioid pain product MoxDuo.

The Anaesthetic and Analgesic Drug Products Advisory Committee has recommended against approval of the immediate-release version of Moxduo, a dual-opioid formulation of morphine and oxycodone, for the treatment of moderate to severe acute pain.

The committee found that QRxPharma failed to provide sufficient evidence to warrant approval of the product at this time.

The FDA has already issued two complete response letters in response to QRxPharma’s New Drug Applications (NDA) for the product. The company filed its third NDA in November.

“We are obviously disappointed in the outcome of [the] meeting, but remain confident in the advantages of Moxduo compared to morphine and oxycodone,” QRxPharma CEO Dr John Holaday said. These include a potentially reduced side-effect profile compared to taking just one opioid.

“We are committed to bringing to market safer therapies for pain, such as Moxduo, and preventing opioid abuse.”

QRxPharma (ASX:QRX) shares fell 80% to $0.14 on Wednesday, and were trading 14.29% lower at $0.12 as of around 1 pm on Thursday.