Off-Label Opioid Promotion: US FDA ‘Does Not Object’ To Intranasal Deterrence Data, Egalet Says
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.
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US FDA advisory committee may not be comfortable with intravenous abuse-deterrence labeling for Rexista (oxycodone extended-release) when the sponsor has not assessed the impact on other routes of abuse purportedly targeted by the formulation.
Intellipharmaceutics seeks oral, intranasal and intravenous abuse-deterrence claims for Rexista (extended-release oxycodone) when it goes before an advisory committee July 26. Even if it passes muster with the US agency under Commissioner Scott Gottlieb, patent and exclusivity issues could impact market availability and labeling.
AbbVie and Daiichi tell US FDA that manufacturers’ communications should not be considered protected speech if they infringe exclusivity rights of other companies; comments seem aimed at restricting what competitors can say about protected claims for Humira and MorphaBond.