Approval granted for management of severe pain
Egalet Corporation announced that the FDA has granted tentative approval for an expanded label for Arymo ER (morphine sulfate) extended-release (ER) tablets C-II 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.
The FDA has issued tentative approval for a supplement submitted earlier in 2017 to update the Arymo ER prescribing information with data from a Category 2/3 intranasal human abuse potential (HAP) study and an intranasal abuse-deterrent claim. This data was previously excluded from the label at original new drug application (NDA) approval due to exclusivity granted to another company. The final approval is expected to be granted when the exclusivity period expires on 2 October 2018.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
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