QRxPharma meets with FDA about MoxDuo IR knockback
Monday, 20 August, 2012
QRxPharma (ASX:QRX) is hopeful it can convince the US FDA to approve MoxDuo IR based on existing trial data, following a meeting with the agency to discuss why its application was knocked back in June.
During the meeting, the FDA requested additional analysis of trials completed to date, including a study completed after QRxPharma's New Drug Application (NDA) filing for the product.
This study evaluated oxygen desaturation levels in patients administered MoxDuo, compared to those receiving either morphine or oxycodone alone.
Oxygen desaturation arising from ventilatory depression is a leading cause of death from high doses of opioids.
MoxDuo IR is the immediate release version of QRxPharma's proprietary dual-opioid pain formulation. It consists of a 3:2 ratio of morphine and oxycodone.
The company is seeking approval to market the product in the US, but the FDA has held up the process with a call for additional safety and efficacy data.
QRxPharma CEO Dr John Holaday said the company believes that an additional analysis of the results of the study will “provide further safety data to support [FDA] approval of MoxDuo.”
If the analysis is sufficient, QRxPharma will be able to avoid having to conduct another trial to supplement its IND application. The company had projected in July that an additional trial would blow out the approval process by another 12-19 months.
The same projections suggest that with the FDA indicating that data from the oxygen saturation study may be sufficient, it will require around two months to conduct the additional analysis and four months for the FDA to review it.
The FDA's decision in June to request additional data before approving QRxPharma's application for MoxDuo IR caught the industry by surprise, and sent the company's share price tumbling into a slump it has not yet recovered from.
QRxPharma (ASX:QRX) shares were trading 2.14% higher at $0.715 as of around 2:30pm on Monday. But this compares to a price of $1.70 from just before the FDA knockback.
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