Off-Label Opioid Promotion: US FDA ‘Does Not Object’ To Intranasal Deterrence Data, Egalet Says

31 Mar 2017

In decision that reflects policy confluence of opioid abuse deterrence, off-label communications and marketing exclusivity, FDA will allow Egalet to distribute truthful, nonmisleading information about Arymo ER's intranasal abuse-deterrence data even though the long-acting opioid was blocked from receiving a labeling claim.

The US FDA's approval of Egalet Corp.’s Arymo ER (morphine sulfate extended-release) has led to a collision of legal, regulatory and public health policies around the high-profile issues of opioid abuse, off-label promotion and market exclusivity incentives.

The agency appears to have opted for a permissive approach on one of the three prongs to address a public...