Mallinckrodt新型止痛药三期临床研究成功

dejunchem

       Mallinckrodt公司研发的止痛药MNK-795在一项有329名患者参与的三期临床研究中达到了预期目标。这种药物主要适用于减轻病人术后剧烈疼痛。在今年七月，FDA接受了Mallinckrodt公司开展MNK-795的优先评审的申请。公司于最近披露了关于MNK-795的多项研究数据，并表示公司预计这种药物一旦上市后，2017年年销售额将达到2亿美元。

详细英文报道：

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."