Mallinckrodt New Drug Application Granted Priority Review by FDA
Mallinckrodt's MNK-795 - controlled-release oxycodone/acetaminophen combination accepted for filing by U.S. Food and Drug Administration
HAZELWOOD, Mo., Jul 29, 2013 (BUSINESS WIRE) -- Mallinckrodt MNK +2.08% today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for MNK-795 and granted priority review. MNK-795 is a controlled-release oral formulation of oxycodone and acetaminophen that has been studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. FDA priority review is a defined NDA review process used for drugs that, if approved, offer significant improvements in the safety or effectiveness of the treatment when compared to standard applications.
If approved, MNK-795 would be a controlled-release oxycodone and acetaminophen combination medication that has immediate and extended release components. The dosage form was designed using Depomed's advanced Acuform(R) drug delivery technology with tamper-resistant properties.
"Despite the number of available pain medications, patients continue to experience unresolved pain and lack treatment options that offer fast-acting and long-lasting relief. We are pleased the FDA granted priority review designation," said Mark Trudeau, President and Chief Executive Officer, Mallinckrodt Pharmaceuticals. "Mallinckrodt has unique capabilities in complex formulations such as MNK-795 and this marks an important milestone for us as our first NDA acceptance as an independent specialty pharmaceutical company."
Mallinckrodt's submission is based on data from a comprehensive clinical trial program for MNK-795 that included 14 clinical studies with 1,281 patients. The studies evaluated pharmacokinetics, efficacy, safety and abuse liability.
Mallinckrodt is a leading global specialty pharmaceuticals business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents. The company's Specialty Pharmaceuticals segment includes branded and generic drugs, and the Global Medical Imaging segment includes contrast media and nuclear imaging agents. Mallinckrodt has approximately 5,500 employees worldwide with direct sales in roughly 50 countries and distribution in approximately 40 countries. The company's 2012 revenue totaled $2.1 billion. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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