US FDA backs abuse deterrent labeling for Pfizer’s Embeda ER

The US Food and Drug Administration has approved an updated label for pharma giant Pfizer’s (NYSE: PFE) Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, for oral use, CII, to include abuse-deterrence studies. Embeda was first launched in the USA in 2009.

The updated label states that Embeda has properties that are expected to reduce abuse via the oral and intranasal (ie, snorting) routes when crushed. However, abuse of Embeda by these routes is still possible. The updated label also includes data from a human abuse potential study of intravenous (IV) morphine and naltrexone to simulate crushed Embeda. However, it is unknown whether the results with simulated crushed Embeda predict a reduction in abuse by the IV route until additional post-marketing data are available. Embeda is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Pfizer expects Embeda will be available in the US in early 2015.

Post-marketing studies required