FDA knocks back QRxPharma's third Moxduo NDA

QRxPharma (ASX:QRX) has suffered a third regulatory setback in the US for dual-opioid pain drug Moxduo and been informed it needs more clinical information demonstrating the drug’s benefits.

The US FDA has issued a Complete Response Letter (CRL) covering QRxPharma’s third New Drug Application (NDA) for the product.

The agency was following the advice of its Anaesthetic and Analgesic Drug Products Advisory Committee, which last month recommended against approval at this time.

In its latest CRL the FDA indicated that in order to approve Moxduo, it will need clinical information demonstrating that Moxduo provides a clear benefit over oxycodone and morphine - its constituent parts - alone. The benefit can either be in terms of efficacy or safety.

QRxPharma CEO Dr Edward Rudnic said the company plans to request a meeting with the FDA to clarify the steps required to secure approval.

“We will work with the FDA to develop a clinical program that addresses the agency’s feedback and ensure that the completed program will clearly demonstrate Moxduo’s benefits,” he said.

Rudnic was appointed CEO early this month after former chief Dr John Holaday stepped down from the role. The change of guard took place days after the FDA’s advisory committee gave its negative recommendation.

QRxPharma (ASX:QRX) shares were trading unchanged at $0.083 as of around 1 pm on Monday.