Market Overview

UPDATE: FDA Has Approved New Labeling on Pfizer's Embeda


FDA approves labeling with abuse-deterrent features for third extended-release

The U.S. Food and Drug Administration today approved new labeling for Embeda
(morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules,
an opioid analgesic to treat pain severe enough to require daily,
around-the-clock, long-term opioid treatment and for which alternative
treatment options are inadequate. Embeda is the third ER opioid analgesic to be
approved with labeling describing the product's abuse-deterrent properties
consistent with the FDA's 2013 draft guidance, Abuse-Deterrent Opioids –
Evaluation and Labeling
ances/UCM334743.pdf> . The new labeling includes a claim indicating that Embeda
has properties that are expected to reduce oral abuse when the product is

Embeda has properties that are expected to reduce, but not totally prevent,
abuse of the drug when crushed and taken orally or snorted. Embeda works by
releasing only the morphine in the capsule when taken properly. When crushed,
the naltrexone in Embeda blocks some of the euphoric effects of the morphine
and can precipitate withdrawal in persons dependent on opioids.

When swallowed intact, however, Embeda can still be abused or misused because
the naltrexone is not expected to substantially block the euphoric effects of
the morphine. It is unknown whether the abuse-deterrent properties of Embeda
will result in a reduction in abuse by the intravenous route until additional
postmarketing data are available.

Embeda can still be abused or misused by any of these routes, and such abuse or
misuse can cause an overdose that may result in death. If abused, it can also
cause withdrawal in people who are dependent on, or tolerant to, opioids.

"Preventing prescription opioid abuse and ensuring that patients have access to
appropriate treatments for pain are both top public health priorities for the
FDA,” said Sharon Hertz, M.D., acting director of the Division of Anesthesia,
Analgesia, and Addiction Products in the FDA's Center for Drug Evaluation and
Research. “The science behind developing prescription opioids with
abuse-deterrent properties is still evolving and these properties will not
completely fix the problem. But they can be part of a comprehensive approach to
combat the very serious problem of prescription drug abuse in the U.S.”

Embeda is not approved, and should not be used, for as-needed pain relief.
Given Embeda's risks for abuse, misuse, and addiction, it should only be
prescribed to people for whom alternative treatment options are ineffective,
not tolerated or would be otherwise inadequate to provide sufficient pain

Embeda was first approved on August 13, 2009, but was voluntarily withdrawn
from the market in March 2011, due to testing that found stability concerns in
the manufacturing process. The FDA confirmed that these issues were resolved
with its approval of a manufacturing supplement in November 2013.

When Embeda was first approved, the drug was evaluated in a clinical trial of
547 osteoarthritis patients. Additional data from abuse liability studies
conducted in laboratories and in people demonstrated the abuse-deterrent
features of Embeda for certain types of abuse (oral and snorting), when the
product was crushed. The abuse potential for the intravenous route was studied
by simulating the amount of morphine and naltrexone that would be released upon
crushing Embeda. This study demonstrated that Embeda was less attractive to
abusers or less likely to produce a high (lower “Drug Liking” and “Drug High”)
compared with morphine alone. However, it is unknown whether these results with
simulated crushed Embeda predict a reduction in abuse by the intravenous route
until additional postmarketing data are available.

The FDA is requiring postmarketing studies of Embeda to further assess the
effects of the abuse-deterrent features on the risk for abuse of Embeda and the
consequences of that abuse. In addition, Embeda is part of the ER/LA Opioid
Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires
companies to make available to health care professionals educational programs
on how to safely prescribe ER/LA opioid analgesics and to provide Medication
Guides and patient counseling documents containing information on the safe use,
storage, and disposal of ER/LA opioids.

Posted-In: News FDA Press Releases


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