FDA approves abuse-deterrent labeling for Embeda

FDA has approved an updated labeling of morphine sulfate/naltrexone hydrochloride (Embeda,Pfizer) extended-release capsules, CII, to include abuse-deterrent properties.

Prescription drug abuse is the fastest growing drug problem in the United States. The increased use of prescription opioid analgesics has led to an increased rate of unintentional overdose deaths as well as hospital admissions for substance abuse treatment. Abuse deterrent-formulations of opioid medications are designed to make the product more difficult to abuse.

Embeda was originally approved in 2009 as an opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment. Because of the risks of addiction, abuse and misuse with opioids, and because there is a greater risk of overdose and death with extended release opioids, Embeda should be reserved for use in patients for whom alternative treatment options are inadequate. The newly approved labeling indicates that Embeda has properties that are expected to reduce, but not completely eliminate, the potential for abuse via the oral and intranasal routes when crushed.

Embeda is an extended-release capsule containing a combination of morphine sulfate, an opioid analgesic and naltrexone hydrochloride, which acts as an opioid antagonist.  If taken properly, only the morphine is released from the capsule and the naltrexone remains sequestered and inactive. However, when crushed, chewed, or dissolved, both drugs are released and the naltrexone acts to inhibit some of the euphoric effects of morphine and can precipitate withdrawal in an opioid-dependent person. This property is expected to deter abuse and misuse of the drug because it is less likely to produce a high compared with morphine alone.

“Prescription opioids are an important treatment option for people with chronic pain. However, misuse and abuse of opioids in the U.S. is a serious societal concern, which is why the development of abuse-deterrent formulations of these medicines is a high priority,” said Bob Twillman, PhD, director of policy and advocacy, American Academy of Pain Management.

The FDA is requiring postmarketing studies of Embeda to further assess the effects of the abuse-deterrent properties on the risk of abuse and the consequences of that abuse. Embeda is also part of the Extended-release Long-acting Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) that requires manufacturers to ensure that the benefits of a drug product outweighs its risks.

Embeda is expected to be available in the United States in early 2015. 

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Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.