Long-Acting Opioid Painkiller Gains FDA Approval

The FDA approved a morphine sulfate extended-release tablet (Arymo ER/Egalet) to treat severe pain needing “daily, around-the-clock, long-term opioid treatment".

The US Food and Drug Administration (FDA) approved morphine sulfate extended-release tablet (Arymo ER/Egalet) to treat severe pain that warrants “daily, around-the-clock, long-term opioid treatment."

The decision follows a favorable recommendation vote during an independent panel of advisors in August: 18-1 recommended Arymo ER be labeled as “an abuse-deterrent product."

Opioid abuse has reached epidemic proportions causing significant public health concerns. According to the Centers for Disease Control and Prevention (CDC), approximately 78 Americans die from opioid overdose each day.

Officials reported this opioid — with abuse-deterrent properties – is geared to patients who find alternative treatment options inadequate. It is formulated as a very hard pill that’s difficult to crush.

Arymo ER is the first approved product designed Egalet’s Guardian Technology, physicochemical properties to provide a barrier approach to specifically make abuse by injection difficult; intranasal, intravenous, and oral abuse would still be possible.

Results from in vitro testing showed Arymo ER tablets had been approved in three dosage strengths: 15 mg, 30 mg, and 60 mg. the drug is slated for US commercial launch for first quarter 2017.

Bob Radie, president and chief executive officer of Egalet, concluded in a news statement, “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.”

The FDA published briefing materials from the Arymo ER panel meeting in August: “Briefing Information for the August 4, 2016 Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM)