The FDA has approved morphine sulfate extended-release tablets (Arymo ER, Egalet Corporation), a long-term opioid treatment for pain management in cases where alternative treatment options may be inadequate, according to a statement from Egalet.1 Arymo ER has been approved in 3 dosage strengths: 15 mg, 30 mg, and 60 mg. The US commercial launch, utilizing Egalet's established commercial infrastructure, is planned for the first quarter 2017.
A statement from the FDA on the approval addressed the product's labeling, noting "As the FDA reviews new drug applications, the agency works through various issues that may arise, including exclusivity. Another product, MorphaBond, [Inspirion], has marketing exclusivity for labeling describing the expected reduction of abuse of single-entity extended-release morphine by the intranasal route due to physicochemical properties. 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. Because the science of abuse deterrence is still evolving and the agency does not yet know which technologies will ultimately prove most effective in deterring opioid abuse, the agency believes that it is in the interest of public health to encourage development of multiple abuse-deterrent alternatives while continuing to promote and protect innovation."2
Arymo uses Egalet's proprietary Guardian™ Technology—a physical and chemical barrier approach to abuse deterrence without the use of an opioid antagonist—creating tablets that are difficult to manipulate for the purpose of misuse and abuse, according to the statement. Results from in vitro testing demonstrated that the tablets, in comparison to non-abuse-deterrent morphine sulfate extended-release tablets, were better at resisting cutting, crushing, grinding or breaking using a variety of tools.
1. Egalet Receives FDA Approval for ARYMO™ ER (morphine sulfate) C-II, an Extended-Release Morphine Product Formulated with Abuse-Deterrent Properties for Treatment of Chronic Pain [news release]. Wayne, Pa. Egalet. http://egalet.investorroom.com/2017-01-09-Egalet-Receives-FDA-Approval-for-ARYMO-ER-morphine-sulfate-C-II-an-Extended-Release-Morphine-Product-Formulated-with-Abuse-Deterrent-Properties-for-Treatment-of-Chronic-Pain. Accessed January 9, 2017.
2. Impact of Exclusivity on Approval of Arymo ER [news release]. FDA. http://www.fda.gov/Drugs/DrugSafety/ucm535708.htm. Accessed January 9. 2017.
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