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news.Egalet has secured approval from the US Food and Drug Administration (FDA) for Arymo ER (morphine sulfate) C-II, an extended-release morphine product formulated with abuse-deterrent properties for treatment of chronic pain.
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In August 2016, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 18-1 to recommend approval of Arymo ER tablets for pain severe enough to require daily, around-the-clock, long-term treatment, for which other options were inadequate.
Arymo ER uses Egalet's Guardian Technology, a physical and chemical barrier approach to abuse deterrence without using an opioid antagonist.
Egalet said the polymer matrix tablet Guardian Technology leverages a novel application of the well characterized manufacturing process of injection molding, which results in tablets that are hard and difficult to manipulate for misuse and abuse.
Compared to non-abuse-deterrent morphine sulfate extended-release tablets, Arymo ER showed increased resistance to cutting, crushing, grinding, or breaking.
Egalet plans to launch Arymo ER, approved in three dosage strengths: 15 mg, 30 mg and 60 mg, in the US in the first quarter of 2017.
Egalet president and CEO Bob Radie said: "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.
"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.”
Egalet said the approval triggers $40m in new funding from a previously announced senior secured debt financing.