FDA advisory committees recommend approval of Egalet’s abuse-deterrent Arymo ER

The Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration (FDA) voted 18 to 1 to recommend approval of Arymo ER (morphine sulfate).

Arymo ER was developed using Egalet's Guardian Technology to manage pain severe enough to require daily, long-term opioid treatment and for which alternative treatment options are not adequate.

The committees voted that if approved Arymo ER should be labeled as an abuse-deterrent product by the intravenous, nasal and oral routes of abuse.

A final decision by the FDA is expected in mid-October. If approved, Arymo ER could be available by the end of this year.

Egalet president and CEO Bob Radie said: "The Committees' support of Arymo ER labeling as an abuse-deterrent product by the intravenous, nasal and oral routes of abuse is an important step forward in the development of this product candidate.

"We believe Arymo can offer patients, when appropriate, effective pain relief and can deter potential abuse. We will continue to work closely with the FDA over the next few months to bring this product to the market."

Egalet's Guardian Technology can be used to develop combination products that include multiple active pharmaceutical ingredients with same or different release profiles.