This should give us a nice pop today!!!!
Egalet received a letter from the FDA on March 27, 2017 in response to the following two issues raised by Egalet in a meeting with FDA/U.S. Department of Health & Human Services on February 24, 2017:
1.Whether FDA would reconsider its exclusivity determination for MorphaBond with respect to intranasal abuse-deterrent properties; and
2.Whether FDA would likely take enforcement action against Egalet if Egalet disseminated materials to healthcare practitioners regarding ARYMO ER's intranasal abuse-deterrent properties and the studies demonstrating the effects of these properties.
The FDA letter indicated that the first issue remains under consideration.
Regarding the second issue, the FDA letter specifically stated that the Agency "does not object" to Egalet's stated plans for distribution of materials that are "based on the intranasal abuse-deterrence data in its original NDA submission" if the communications are directed only to healthcare professionals, include appropriate disclosures and are otherwise truthful and non-misleading.
ARYMO ER, approved by the FDA on January 9, 2017 in three dosage strengths: 15 mg, 30 mg and 60 mg, 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.
ARYMO ER is the first approved product 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. Results from in vitro testing demonstrated that ARYMO ER tablets, in comparison to non-abuse-deterrent morphine sulfate extended-release 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. Abuse of ARYMO ER by injection, as well as by the oral and nasal routes, is still possible.
