The US FDA's approval of Egalet Corp.'s Arymo ER (morphine sulfate extended-release) with deterrence claims for only one of three routes of abuse may raise concerns that the regulator's decision-making on marketing exclusivity and human abuse liability study endpoints could discourage development of abuse-deterrent opioid formulations.
On Jan. 9, FDA approved Arymo ER with a labeling claim for deterrence by the intravenous route of abuse
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