Embeda regulatory update

King said FDA approved Embeda to manage moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Embeda is an extended-release formulation of morphine, an opioid receptor agonist, which includes a sequestered pellet core of naltrexone. The label includes data from abuse deterrence trials in which the majority of patients reported "reduced drug liking" or reduced euphoria compared with morphine; however, it says that there is "no evidence that the naltrexone in Embeda reduces the abuse liability." King said it did not seek labeling language with a claim of abuse deterrence, but did say that it plans to discuss with FDA what data would be necessary to demonstrate such an effect. ...