Egalet Receives FDA Approval for Extended-Release Product Formulated With Abuse-Deterrent Properties

Egalet Corporation recently announced the US FDA has approved 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.

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.

“Given the need for treatments for the millions of Americans living with chronic pain, the growing problem of prescription abuse and the fact that we know diversion is a huge problem, it is important that we have more abuse-deterrent treatment options, like ARYMO ER, if and when these pain treatments end up in the wrong hands,” said Nathaniel Katz, MD, neurologist and pain specialist as well as founder and President of Analgesic Solutions.

ARYMO ER has been approved in three 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.

“With the majority of ER opioids in easy-to-abuse forms, it is important that healthcare professionals have additional treatment options like ARYMO ER that are resistant to different methods of manipulation using a variety of tools,” said Bob Radie, President and Chief Executive Officer of Egalet. “ARYMO ER has physical and chemical properties expected to make abuse by injection difficult, which is important given it is the most common non-oral route of morphine abuse and the most dangerous. With our commercial organization in place, we are ready to launch ARYMO ER in the first quarter of 2017.”

The FDA approval of ARYMO ER triggered $40 million in new funding to Egalet from the second tranche of the senior secured debt financing previously announced on August 31, 2016. In connection with the second tranche, the note purchasers will also receive a royalty right, representing a right to receive an aggregate 1.5% royalty payment on net sales of ARYMO ER, as further described in Egalet’s current report on form 8-K filed on September 1, 2016.

Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing, and commercializing innovative treatments for pain and other conditions. Egalet has three approved products: ARYMO ER (morphine sulfate) extended-release tablets for oral use only CII, developed using Egalet’s proprietary Guardian Technology, OXAYDO (oxycodone HCI, USP) tablets for oral use only CII and SPRIX (ketorolac tromethamine) Nasal Spray. Using Guardian Technology, Egalet is developing a pipeline of clinical-stage, product candidates, including Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation 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.

Guardian Technology can be applied broadly across different classes of pharmaceutical products and can be used to develop combination products that include multiple active pharmaceutical ingredients with similar or different release profiles. For more information, visit egalet.com.