Alpharma files NDA for Embeda

Embeda combines an extended release opioid agonist with sequestered naltrexone, an opioid antagonist. In clinical trials, when Embeda was taken as directed, it provided pain relief and the naltrexone remained sequestered in the pellet core while passing through the gastrointestinal tract without significant absorption.

Dean Mitchell, president and CEO of Alpharma, said: “Today’s announcement is an important one for all stakeholders in Alpharma. While we recognize the significance of company’s first submission of a NDA, we are also keenly aware of the growing problem of opioid abuse in our country.”