Updated label from FDA for Embeda for Severe Pain- Pfizer

Pfizer Inc.announced that the FDA has approved an updated label for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, for oral use, CII, to include abuse-deterrence studies. The updated label states that Embeda has properties that are expected to reduce abuse via the oral and intranasal (i.e., 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 postmarketing 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 U.S. in early 2015.