Eaglet Corp. recently reported that two U.S. Food and Drug Administration (FDA) advisory committees voted to recommend the approval of ARYMO ER.
The vote came at the joint meeting between the Anesthetic and Analgesic Drug Products Advisory Committee and the FDA’s Drug Safety and Risk Management Advisory Committee.
ARYMO ER was developed using Egalet’s Guardian Technology and is designed to treat severe pain that requires daily and around-the-clock therapies that involve long-term opioid treatment. ARYMO ER also treats pain for which there are no alternative or inadequate means of treatment.
"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," Egalet president and CEO Bob Radie said. "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.”
During the joint meeting the committees voted that ARYMO ER should be labeled as a deterrent to oral, nasal and intravenous abuse if it receives approval by the FDA.
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