Mallinckrodt ($MNK) scored FDA approval for its Xartemis XR oxycodone and acetaminophen tablet, known in development as MNK-795, an opioid treatment for acute pain. The approval is also a win for Depomed ($DEPO), which owns the controlled-release technology and collected $10 million in a milestone payment.
Xartemis, which uses Depomed's Acuform technology to extend the release to about 8 to 10 hours, was put up for priority review in the middle of last year, at which point Depomed also collected a $5 million milestone. According to the agreement, Depomed will also get royalties in the "high single digits" on sales of the drug.
Newark, CA-based Depomed's tech has given it several other partnerships, including with two companies for their diabetes drugs--Salix ($SLXP)-owned Santarus' Glumetza and Merck's ($MRK) Janumet--as well as Johnson & Johnson's ($JNJ) Janssen for its pain drug, Nucynta.
The Acuform delivery platform uses polymers that swell enough to allow a tablet to remain in the stomach for hours at a time. The gradual release allows for more of the drug to be absorbed in the gastrointestinal tract for a more effective outcome and increased tolerability, the company says. That allows for once- or twice-daily dosing.
More cash could be on the way for Depomed, as Mallinckrodt readies its MNK-155 pain treatment--also using Depomed's tech--for an NDA later this year. That would give Depomed another $5 million upon acceptance of the application with $10 million more upon approval, if all goes well.
"Acute pain doesn't last for only four to six hours, and neither should its treatment," Tufts University medical professor Nathaniel Katz said in a statement. "With the extended-release profile of Xartemis XR, patients may not need to wake in the night to take a dose. A long-acting combination analgesic that can effectively deliver oxycodone and acetaminophen for acute pain patients experiencing pain throughout the day and night is a welcome addition to the treatment landscape."
The approval comes on the heels of a pivotal Phase III efficacy study for postsurgical pain, where the drug met its endpoint and showed significantly improved pain scores over 48 hours, according to Mallinckrodt.
"We are pleased the FDA has approved Xartemis XR and that our Acuform technology has contributed to this important new therapy option for patients and their physicians," Depomed CEO Jim Schoeneck said in a statement.
- here's Mallinckodt's release
- and Depomed's release