Drug Profile

Morphine extended-release/naltrexone

Alternative Names: ALO-01; Embeda; KADIAN NT; Morphine ER/naltrexone; Naltrexone/morphine ER

Latest Information Update: 05 Nov 2023

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At a glance

Originator Alpharma
Developer Pfizer
Class Ethers; Ketones; Morphinans; Morphine derivatives; Opioid analgesics; Small molecules
Mechanism of Action Opioid mu receptor agonists; Opioid receptor antagonists

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

Highest Development Phases

Market Withdrawal Pain

Most Recent Events

17 Oct 2014 The US FDA approves sNDA for Pain
29 Jul 2014 The US FDA extends PDUFA date to October 2014 for sNDA review for Pain (PO)
29 Jul 2014 The US FDA sets PDUFA date of July 2014 for sNDA review for Pain (PO)

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