QRxPharma abandons MoxDuo development

QRxPharma (ASX:QRX) shares plunged around 50% after the company announced it is abandoning further development of dual-opioid pain drug MoxDuo.

After meetings with the US FDA to discuss its third knockback of the New Drug Application (NDA) for the product, the company has decided to halt all development of the MoxDuo immediate release, controlled release and intravenous products.

During the meetings the FDA made clear that QRxPharma would likely need to conduct a repeat phase II trial, followed by one or more phase III studies.

The QRxPharma board said it had determined that the cost of these additional trials would not be justifiable given the limited residual patent life for the products.

In response to the decision to halt development, QRxPharma will act to cut all non-essential expenditure, retaining only a small team to explore alternative avenues for the company and its assets.

The move comes one month after QRxPharma’s chairman and three directors - including founder Dr Gary Pace - stepped down from their roles in response to a board spill vote spearheaded by disgruntled shareholder Langley Walker.

QRxPharma’s CEO Dr John Holaday also stepped down in May after an advisory committee to the FDA recommended against approving the company’s MoxDuo NDA - a recommendation that the agency subsequently accepted.

The company ended the last financial year with cash reserves of $10.5 million, but has set aside $3.6 million to cover liabilities including termination payments for Holaday and other employees. QRxPharma said it expects to have cash reserves of around $3 million by end-September.

QRxPharma (ASX:QRX) shares were trading 47.95% lower at $0.038 as of around 1 pm on Thursday.