FDA Panels Back Abuse-Deterrent Arymo ER for Severe Pain

Deborah Brauser

August 05, 2016

UPDATED August 10, 2016 // Two US Food and Drug Administration (FDA) panels — the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) — voted 18 to 1 in favor of recommending approval of the abuse-deterrent opioid (Arymo ER, Egalet Corp) for severe pain.

The full indication would be "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."

"I think that the replacement of long-acting morphine with this drug or other drugs like it will be a step forward," said meeting chairperson Raeford E Brown Jr, MD, professor of anesthesiology and pediatrics in the College of Medicine at the University of Kentucky, Lexington.

Dr Brown noted that there are currently 6 million prescriptions per year for long-acting morphine, "and right now we're not doing a good job of reducing that number."

Randall P. Flick, MD, medical director of the Mayo Clinic Children's Center in Rochester, Minnesota, also voted "yes" but said he was doing so somewhat reluctantly. "At some point the agency and the committee is going to have to address the question of whether these drugs have an indication at all," said Dr Flick.

"Unfortunately, we're probably in a position that the lesser of two evils is to approve this drug."

Interestingly, the only "no" vote could have gone either way. Anita Gupta, DO, PharmD, said she was "on the fence" because the question of its long-term efficacy remains unanswered.

"I do see that there is a definite need for innovation and advances. But I felt more information was necessary," said Dr Gupta.

The drug manufacturer noted that if the FDA follows the panel's overall recommendation, this would be the first commercially available product to use its Guardian Technology, which was created to reduce, albeit not completely prevent, abuse of the drug if the product is manipulated by a user. This could include trying to chew, snort, or inject the drug.

The extended-release morphine product comes in a hard, dense tablet to keep it from being easy to chew or crush. And if it's combined with a liquid, it turns into a gel, making injection difficult.

Panel members largely agreed that the product does deter abuse risk. In addition to voting overwhelmingly for approval, they voted 18-1 that the drug should be labeled both as an abuse-deterrent product by the nasal and intravenous routes of abuse. Dr Gupta again registered the "no" votes.

The panel voted 16-3 that the label should also mention that the drug deters abuse via oral route.

Support for abuse deterrent labeling "is an important step forward in the development of this product candidate," said Bob Radie, president and CEO of Egalet, in a release.

During an investors' conference call after the AADPAC-DSaRM meeting, Radie noted that the company will continue to work with the FDA to complete the review process for the new drug approval.

"There is significant need for treatment options that will deter abuse while still providing individuals with effective pain relief," said Radie. During the panel meeting earlier, he stated that "We're not advocating for just another morphine pain medication. Rather, we believe that this can be an important part of the abuse deterrent effort."

The target date for an approval decision by the FDA is October 14, said the release. And if approved, the company plans to have the product on shelves by the first quarter of 2017.

There are currently six approved extended-release opioid analgesic products with abuse-deterrent properties: OxyContin, Targiniq, Embeda, Hysingla ER, Morphabond, and Xtampza ER.

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