Pfizer’s Embeda Joins Abuse-Deterrent Club, But FDA Wants Assurances

 
• By Derrick Gingery

As with Purdue’s Targiniq, agency requires a post-marketing study to determine whether the new morphine/naltrexone formulation actually deters abuse.

Pfizer Inc.’s Embeda has become the third extended-release opioid product to gain an abuse-deterrent claim, but FDA still is hedging its bets on the extent of the properties’ effectiveness.

The company must complete a post-marketing epidemiological study to further evaluate the abuse-deterrent aspects of the opioid analgesic product (morphine...

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