Egalet receives FDA tentative approval for expanded label for ARYMO ER

Friday, December 15, 2017

Egalet, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, announced that the FDA has granted tentative approval for an expanded label for ARYMO ER (morphine sulfate) extended-release (ER) tablets C-II 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 FDA has issued tentative approval for a supplement submitted earlier in 2017 to update the ARYMO ER prescribing information with data from a Category 2/3 intranasal human abuse potential (HAP) study and an intranasal abuse-deterrent claim. This data was previously excluded from the label at original new drug application (NDA) approval due to exclusivity granted to another company. The final approval is expected to be granted when the exclusivity period expires on October 2, 2018.

ARYMO ER, developed using 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, was approved on January 9, 2017. Results from in vitro testing demonstrated that ARYMO ER tablets, in comparison to non-abuse-deterrent morphine sulfate extended-release (ER) tablets, have increased resistance to cutting, crushing, grinding or breaking using a variety of tools. Due to its physical and chemical properties, ARYMO ER is expected to make abuse by injection difficult.

“Given that extended-release morphine is the most frequently prescribed ER opioid for individuals living with chronic pain and the majority of those prescriptions are in easy to abuse formulations, we believe that strengthening the ARYMO ER label to include additional abuse-deterrent data is an important improvement for chronic pain patients and their communities,” said Mark Strobeck, Ph.D., chief operating officer of Egalet. “While opioids should be reserved for situations when all other alternative therapies have been tried, when opioids are needed, having abuse-deterrent options is important.”

The Category 2/3 intranasal HAP study was conducted in accordance with the FDA Guidance for Industry, Abuse-Deterrent Opioids – Evaluation and Labeling. It was a single-center, randomized, double-blind, double-dummy, active and placebo-controlled, five period crossover study which assessed the abuse potential of ARYMO ER versus MS Contin® (non-abuse-deterrent morphine sulfate extended-release tablets) in 46 nondependent, recreational opioid users when administered intranasally. The study met its primary endpoint, demonstrating that after insufflation, manipulated ARYMO ER led to significantly (P<0.0001) less drug liking compared with crushed MS Contin. The study also concluded that subjects administered manipulated ARYMO ER intranasally reported a significantly decreased likelihood to take the drug again (P<0.0001) compared with crushed MS Contin. Consistent with these findings, manipulated ARYMO ER demonstrated a similar pharmacokinetic (PK) profile to intact ARYMO ER, whereas crushed MS Contin’s PK profile was consistent with conversion of an opioid from an extended-release to an immediate release absorption profile.

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