Under FDA priority review, Mallinckrodt's pain med succeeds in PhIII

Mallinckrodt ($MNK) has rolled out upbeat data from a Phase III study of its experimental pain drug MNK-795 for quelling acute pain in patients after surgeries to remove their bunions. In July, the FDA accepted a new drug application for the therapy, an oral extended-release formulation of oxycodone and acetaminophen, for priority review.

At the PAINWeek meeting this week in Las Vegas, the Dublin, Ireland-based specialty drugmaker is presenting multiple studies on MNK-795 ahead of a hoped-for product approval and U.S. launch. The drug could fetch annual sales of up to $200 million by 2017, BMO Capital Markets analyst David Maris said, as quoted by Reuters. And this makes the pain med an important product for Mallinckrodt, which spun off from Covidien ($COV) earlier this year after contributing $2.1 billion in sales to the healthcare giant in 2012.

Formulated with Acuform drug delivery tech from Depomed ($DEPO), MNK-795 can be taken once every 12 hours and offers the level of resistance to tampering with the product for illicit use. These attributes could help differentiate the product in the competitive market for pain drugs, which include plenty of inexpensive generic treatments. In gaining priority review for the drug from U.S. regulators, the company showed that its new pain med could offer an improvement over low-cost rival meds.

In the Phase III study, investigators compared MNK-795 with placebo in 329 patients with acute pain after their bunion surgeries, and the experimental treatment achieved its primary goal of improvement in pain scores versus placebo over 48 hours.

"We are pleased that MNK-795 met the primary endpoint of the study," Dr. Tom Smith, Mallinckrodt's chief medical officer, said in a statement, "and we are excited to be able to share the clinical story for this product by presenting these and other data at PAINWeek."

- here's the release
- see Reuters' article

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