|Depomed's oral tech increases upper GI tract delivery.--Courtesy of Depomed|
Mallinckrodt ($MNK) and Depomed ($DEPO) welcomed the FDA's priority review acceptance of an application for the companies' new oral pain drug that makes use of Depomed's controlled-release Acuform technology.
Mallinckrodt's MNK-795 is an oral combination of oxycodone and acetaminophen designed to treat moderate to severe acute pain. With Depomed's Acuform delivery platform, the controlled-release form allows the tablet to be retained in the stomach for about 8 to 10 hours. Because most of the absorption occurs in the upper gastrointestinal tract, Acuform allows for a higher dose of the drug over a longer period of time, an important consideration when treating for pain.
With the FDA's acceptance of the NDA, Depomed collected $5 million from Mallinckrodt in milestone payments. And the California company stands to gain more upon approval, as well as royalties on net sales. The FDA's priority review indicates a commitment by the agency to finish the approval process within 6 months and is given to drugs that "offer significant improvements in the safety or effectiveness of the treatment when compared to standard applications," according to Depomed.
Depomed is also applying its Acuform technology to several other partnerships with drugs on the market: Santarus' Glumetza, Merck's ($MRK) Janumet and Johnson & Johnson's ($JNJ) Janssen-based Nucynta.
- here's the Mallinckrodt release
- and the release from Depomed