QRxPharma to refile MoxDuo NDA next month

QRxPharma (ASX:QRX) aims to refile its New Drug Application for dual-opioid pain drug candidate MoxDuo with the US FDA by mid-November.

Once the company has submitted the new application, the FDA will set a six-month deadline for deciding whether to approve the drug, QRxPharma said in a filing.

After a scheduled meeting with the FDA to discuss the regulator’s issue of a second Complete Response Letter in August, the company now has a greater understanding of the requirements for a new submission, the filing states.

During the meeting, the FDA reaffirmed that the safety and efficacy of MoxDuo are not in question. The regulator confirmed that new analysis of data from one safety study will help shape its final decision.

The FDA’s latest CRL concentrated on data from a study on the respiratory safety advantages of MoxDuo compared to equally effective doses of morphine or oxycodone. In response, QRxPharma commenced a full audit of over 30 million data points for oxygen saturation from the study.

“The tone of the meeting with the FDA was cordial and constructive, providing clear recommendations on how we should revise our NDA and document our validated data from the respiratory safety study,” QRxPharma CEO Dr John Holaday said.

“We are highly confident in the integrity of the data defining the respiratory safety advantages of MoxDuo and are now completing the documents for refiling.”

MoxDuo is a formulation of morphine and oxycodone. If the FDA approves QRxPharma’s NDA, the company aims to launch the product in the US in 2014. The company will also use the revised NDA as a basis for starting the approvals process in Australia, Europe and other markets.

QRxPharma (ASX:QRX) shares were trading 2.78% lower at $0.70 as of 2.30 pm on Wednesday.