QRxPharma shares tumble after FDA knockback for MoxDuo IR

Despite industry confidence that QRxPharma (ASX:QRX) would be granted marketing approval for its pain drug, MoxDuo IR, the US Food and Drug Administration has issued a Complete Response Letter requesting additional information on safety and effectiveness, sending the company’s shares into freefall in morning trading.

As of 1pm, QRX shares were trading at 74c, down 56.5% for the day. The closing price on Monday was steady at $1.68, dropping to 63c immediately after the market opened this morning.

MoxDuo IR is a dual-opioid pain drug that combines morphine and oxycodone in a 3:2 ratio. There are three formulations of MoxDuo, with IR being the immediate release version for treating acute moderate to severe acute pain.

Being a combination therapy of two well known drugs, and backed by positive trial results, the industry was generally optimistic that MoxDuo IR would be given the go ahead by the FDA.

The Complete Response Letter represents a significant setback for the company, and raises the prospect of further trials to gather additional data, which could prove a costly delay.

QRxPharma has partnered with Actavis to help market MoxDuo in the US. Actavis CEO, Doug Boothe, expressed disappointment at the response from the FDA.

“While we are disappointed by the Complete Response Letter, we are supporting of QRxPharma’s continued efforts to work with the FDA to fully address their questions in a timely manner,” he said.

QRxPharma has released a statement saying it is considering its response to the requests made by the FDA for additional information on safety and effectiveness.

“We remain confident in MoxDuo as a potential therapeutic option for the millions of patients suffering from moderate to severe acute pain and will continue our efforts to bring this therapy to market.” Said QRxPharma Managing Director and CEO, John Holaday.

QRxPharma now has up to one year to resubmit its application with the FDA.

ALS contacted QRxPharma for comment and will provide updates as more information comes to hand.