FDA Tentatively Approves Arymo ER Label Update for Abuse-Deterrent Claims
Clinical data have shown a greater resistance to cutting, crushing, grinding, or breaking with Arymo ER when compared to non-abuse-deterrent morphine sulfate extended-release tablets.
Egalet announced that the Food and Drug Administration (FDA) has tentatively approved an update to the Arymo ER (morphine sulfate) extended-release tablets labeling to include data from a Category 2/3 intranasal human abuse potential (HAP) study and an intranasal abuse-deterrent claim.
The single-center, randomized, double-blind, double-dummy, active- and placebo-controlled, 5 period crossover study (N=46) evaluated the abuse potential of Arymo ER vs MS Contin in non-dependent, recreational opioid users when given intranasally. The primary endpoint was achieved, showing that after insufflation, manipulated Arymo ER resulted in significantly less (P <.0001) drug liking vs crushed MS Contin.
Moreover, the data showed patients given manipulated Arymo ER intranasally had a significantly reduced likelihood of taking the drug again (P <.0001) vs crushed MS Contin. This data was not included in the original New Drug Application (NDA) label at time of approval due to exclusivity granted to another company. The final approval is anticipated when the exclusivity period ends on October 2, 2018.
Arymo ER, a CII controlled substance, is 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. The Company's Guardian Technology allows for the development of tablets that are difficult to manipulate for misuse and abuse.
Clinical data have shown a greater resistance to cutting, crushing, grinding or breaking when compared to non-abuse-deterrent morphine sulfate extended-release tablets; abuse via injection is also expected to be difficult based on its physical and chemical properties.
Arymo ER is available as 15mg, 30mg, and 60mg strength extended-release tablets in 100-count bottles.
Egalet receives FDA tentative approval for expanded label for Arymo® ER (morphine sulfate) C-II, an extended-release morphine product formulated with abuse-deterrent properties for treatment of chronic pain [press release]. Wayne, Pennsylvania: Egalet; December 15, 2017. Accessed January 8, 2018.