Mallinckrodt 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, which owns the controlled-release technology and collected $10 million in a milestone payment.
Mallinckrodt and Depomed welcomed the FDA's priority review acceptance of an application for the companies' new oral pain drug that makes use of Depomed's controlled-release Acuform technology.
Depomed took a 10% hit on its stock price mid-day Monday after FDA advisers turned thumbs down on their drug to ease symptoms of hot flashes in a lopsided "no" vote. By a vote of 12 to 2 the outside advisers voted against recommending an approval for Sefelsa, concluding that the company had failed to demonstrate that the drug worked as billed.
Depomed shares spiked yesterday as the company races with Hisamitsu to garner the first FDA approvals of non-hormonal drugs for tempering hot flashes, even though Depomed's drug fell short of efficacy goals in trials.
Depomed chalked up a couple of much-needed wins in its ongoing fight to protect its shingles pain drug Gralise from generic competition.
Depomed has released full data from its Phase III Breeze 3 trial of Serada, a controlled-release, oral, non-hormonal treatment for menopausal hot flashes (or hot flushes, if you are from the U.K.). This includes a new statistical analysis of the data, which the company carried out after a discussion with the FDA.
Depomed won FDA approval for its shingles-pain drug Gralise under the agency's Orphan Drug program. Now, the company wants the Orphan Drug exclusivity to go along with it.
In the latest of a series of licensing deals, Depomed ($DEPO) has licensed its Acuform gastric retentive drug delivery technology to Janssen Pharmaceuticals in a non-exclusive deal, leading to a premarket share jump of 8.6%, according to The Wall Street Journal. The polymers in Acuform swell in the stomach, releasing the active drug gradually over 8 or 9 hours.
Depomed ($DEPO) disappointed in its third shot at a Phase III win for its drug Serada as a treatment for menopausal hot flashes, but the Menlo Park, CA-based firm's executives have given no
Depomed has definitely learned the art of the deal. Ironwood Pharmaceuticals is the latest in a growing list of companies partnering with Depomed for its promising drug-delivery technology called