QRxPharma may face more trials for MoxDuo

QRxPharma (ASX:QRX) will meet with the US FDA in August to discuss the issues the agency has with its NDA for dual-opioid pain formulation MoxDuo IR.

QRxPharma (ASX:QRX) is counting on an August meeting with the US FDA to determine the steps needed to clear pain formulation MoxDuo IR in the US, after a knockback by the agency last month.

The FDA last week unexpectedly issued QRxPharma a Complete Response Letter in relation to the company's New Drug Application (NDA) for MoxDuo IR, a proprietary formulation of morphine and oxycodone.

QRxPharma CEO John Holaday said the agency has so far only indicated that it has issues with the data provided to satisfy the combination rule, which requires QRxPharma to prove that MoxDuo is safer or more effective than using morphine and oxycodone in combination.

“The only query the FDA has raised is in relation to the combination rule, but it has not been explicit in describing its concerns with QRxPharma’s application,” Holaday said.

Holaday and COO Dr Ed Rudnic told an investor briefing last week that the company was completely blindsided by the decision, and that it conflicts with the guidance the FDA had provided during the application process.

No issues with the application were brought up during QRxPharma's prior meetings with the FDA, neither at the end-of-phase-II, the pre-NDA or the NDA application filing stage.

The company has reached out to the FDA and arranged an August meeting to discuss outstanding issues with the NDA. Holaday said he was pleased with the agency's rapid response to QRxPharma's request for a meeting, which was agreed to by the FDA within 24 hours.

The meeting will allow the company to ascertain whether more clinical trials will be needed to support the application, which would significantly delay the process.

Holaday said the company's most important next step is “establishing exactly what the FDA requires to bring MoxDuo to an Approved status.”

He said it is premature to speculate whether additional trials will be needed, but added that based on feedback provided throughout the process, “we strongly believe that our submission was more than adequate for approval.”

At the investor briefing, participants were told that it is entirely possible that the FDA just needs a new analysis of the existing trial data. QRxPharma has also collected additional clinical data that was not included as part of the NDA, but that may be able to be used to address the concerns.

According to Bioshares, in a positive scenario, the FDA may just have issues with the analysis of the clinical data. This would likely require around two months for QRxPharma to recrunch the numbers, and around four months for the FDA to review the altered application. But if additional clinical trials are required, this could delay the process by between 12 and 19 months, depending on the size of the trial required.

Gaining FDA approval for MoxDuo IR is particularly important because the NDA process is expected to set the stage for QRxPharma's subsequent application for the controlled release variant of the drug, MoxDuo CR.

QRxPharma has partnered with Actavis to commercialise MoxDuo IR in the US.

The FDA's surprise decision sent QRxPharma shares tumbling into a rut they have yet to emerge from. QRxPharma (ASX:QRX) shares were trading at $0.615 as of 10am on Wednesday, down from $1.700 just before the company disclosed the FDA's decision.

Bioshares does not expect the share price to recover until at least after the FDA meeting in August.