Two FDA panels––the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee––have recommended the approval of Arymo ER (Egalet Corporation), an abuse-deterrent, extended-release, oral morphine formulation. If cleared, the product will be indicated 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.
Egalet submitted a new drug application to the FDA in December 2015.
Arymo ER tablets are designed to be extremely hard, making them more difficult to break down to extract the active ingredient. When brought in contact with liquid, they turn into a sticky gel that is difficult to inject with a syringe. The FDA’s advisory panels said that Arymo ER deters, but does not eliminate, the risk of abuse if addicts try to snort, chew, or inject the tablets.
The abuse-deterrent development program for Arymo ER included two phase 3 human abuse potential (HAP) studies that evaluated the manipulated oral and nasal routes of abuse. Key findings include:
- The oral HAP study met its primary endpoint by demonstrating a statistically significant reduction in maximum drug liking for manipulated Arymo ER compared with crushed MS Contin (extended-release morphine sulfate, Purdue Pharma) (P = 0.0069).
- The intranasal HAP study also met its primary endpoint by demonstrating statistically significant reductions in maximum drug liking for two treatment arms of manipulated Arymo ER (i.e., with and without sieving to remove large particles that were difficult to snort) compared with crushed MS Contin (P < 0.0001 for both arms).
In June, FDA advisors recommended the approval of ALO-02 (oxycodone/naltrexone, Pfizer), a long-acting, abuse-deterrent opioid, although they had reservations about the drug’s ability to curb all forms of abuse. The panel also backed the approval of another long-acting opioid, Vantrela ER (hydrocodone bitartrate, Teva), saying it was likely to deter abuse whether addicts sought to swallow, snort, or inject it.
The Centers for Disease Control and Prevention estimates that 78 Americans die every day from opioid overdose.
Sources: Reuters(link is external); August 4, 2016; and FDA Briefing Document; August 2, 2016.
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