NEW YORK CITY (dpa-AFX) - Drugmaker Pfizer Inc. (PFE) said Friday that the United States Food and Drug Administration has approved an updated label for Embeda extended-release 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 routes when crushed. However, abuse of Embeda by those routes is still possible.
The updated label also includes data from a human abuse potential study of intravenous 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.
Embeda capsules consist of extended-release morphine sulfate and sequestered naltrexone hydrochloride, an opioid antagonist. Naltrexone is intended to remain sequestered when the product is taken as directed. The in vitro and pharmacokinetic data demonstrate that crushing Embeda pellets results in the simultaneous release and rapid absorption of morphine sulfate and naltrexone hydrochloride.
Embeda is the first and only approved morphine specifically designed to deter certain forms of abuse. Pfizer has decided to remove its non-abuse deterrent morphine formulation, Avinza extended-release capsules CII from the U.S. market and notified the FDA earlier this year of the intent to discontinue manufacturing of the product.
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