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Egalet Corporation, a fully integrated specialty pharmaceutical company, announced that the joint meeting of 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 proprietary Guardian Technology 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.
The committees also voted:
- 16 to 3 that if approved,Arymo ER should be labeled as an abuse-deterrent product by the oral route of abuse;
- 18 to 1 that if approved,Arymo ER should be labeled as an abuse-deterrent product by the nasal route of abuse; and
- 18 to 1 that if approved,Arymo ER should be labeled as an abuse-deterrent product by the intravenous route of abuse.
"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," said Bob Radie, president and CEO of Egalet. "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."
Based on the committees' votes, Egalet anticipates, if approved, the label for Arymo ER will describe the product's abuse-deterrent properties that are expected to reduce, but not totally prevent, abuse of the drug when the tablets are manipulated. The FDA is not bound by the recommendations of its advisory committees, but will consider their guidance during the review of the NDA for Arymo ER. The FDA Prescription Drug User Fee Act (PDUFA) goal date for a decision is October 14, 2016.
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