FDA’s Approval of a New Abuse-Deterrent Opioid Raises Questions

Posted 10 January 2017 By Zachary Brennan

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The US Food and Drug Administration (FDA) on Monday raised some eyebrows with its approval of another long-acting opioid, Egalet’s Arymo ER (morphine sulfate extended-release tablets), with abuse-deterrent properties.

What makes this approval unique is not only the oddly-worded FDA explanation of an another opioid's marketing exclusivity in relation to this approval, but the agency overriding a nearly unanimous advisory panel of outside medical experts.

Back in August, an FDA advisory panel voted not only for the drug’s approval, according to Medscape, but 18-1 that the drug should be labeled as having abuse deterrent properties for the nasal and intravenous routes, as well as 16-3 in favor of the label mentioning the drug can deter oral abuse too (even though, as FDA notes, deterrence does not mean that abuse by the intravenous, intranasal and oral routes is impossible).

However, running counter to the panel’s recommendations, FDA on Monday said the drug is “formulated to give it physicochemical properties expected to make abuse by injection difficult.”

The agency did not mention if the drug can deter abuse via the nasal or oral routes, other than to explain that another similar opioid, Daiichi Sankyo’s MorphaBond (morphine sulfate extended-release tablets), has marketing exclusivity for a label that says the product can reduce abuse via the intranasal route.

“Due to MorphaBond’s marketing exclusivity, no other single-entity extended-release morphine product submitted in an abbreviated new drug application or 505(b)(2) application can be approved for that use at this time,” FDA explained Monday. Arymo ER was approved under the 505(b)(2) pathway.

Or to put it more simply: There’s another powerful opioid about to hit the US market, an independent panel of medical experts advising FDA voted overwhelmingly in favor of labeling this opioid as an opioid with abuse-deterrent properties, but because of marketing exclusivity, the new opioid’s label cannot yet explicitly make the claim that the opioid's properties deter snorting.

The agency also did not explain why it overruled its advisory panel and did not approve an Arymo label that said the drug could deter oral abuse.

An FDA spokesman told Focus on Tuesday: “The labeling for Arymo ER and MorphaBond conveys that each drug is expected to deter intravenous abuse. This labeling is not protected by 3-year exclusivity. The studies which assessed abuse-deterrence for the intravenous route of abuse were in vitro studies. In vitro studies may not form the basis for eligibility of 3-year exclusivity – new clinical studies must be conducted for a drug to be considered eligible for 3-year exclusivity, and in vitro studies are not clinical studies.”

And once MorphaBond’s exclusivity expires 2 October 2018, FDA said it can approve labeling for a product that includes "information describing the expected reduction of abuse of single-entity extended release morphine by the intranasal route due to physicochemical properties.” 

Daiichi Sankyo spokeswoman Alyssa Dargento told Focus: "We are aware of the recent FDA action and do not have a comment at this time. We are currently focused on the launch of MorphaBond ER (morphine sulfate) extended-release tablets. Opioid medications are an important, well-established therapeutic option for physicians who treat pain, but they can also present serious risks if abused or misused. Abuse-deterrent formulations of opioids, such as MorphaBond ER, offer healthcare providers additional valuable tools in the fight against the potential for misuse and abuse while at the same time helping to provide patients relief from their chronic pain."

Editor's note: Article updated 1/11 with comment from Daiichi.

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Categories: Drugs, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: opioid, opioid abuse, marketing exclusivity, FDA drug approval, abuse-deterrent opioid

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