FDA Approves New Long-Acting Opioid for Severe Pain

The Food and Drug Administration (FDA) has approved Egalet’s long-acting opioid, Arymo (morphine sulfate) extended-release (ER) tablets.

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. 

The same committee had recommended Arymo ER be labeled an abuse-deterrent product by the oral route of abuse (16-3), by the nasal route of abuse (18-1), and by the intravenous route of abuse (18-1). 

Arymo ER was developed as hard pills that are difficult to crush and manipulate, which can reduce the potential for abuse. It uses Egalet’s Guardian Technology, a physical and chemical barrier approach to abuse deterrence without using an opioid antagonist. Compared to non-abuse-deterrent morphine sulfate extended-release tablets, Arymo ER demonstrated increased resistance to cutting, crushing, grinding, or breaking. 

Morphine sulfate, an opioid agonist, is relatively selective for the mu receptor but it can interact with other opioid receptors at higher doses.

For more information call (610) 833-4200 or visit Egalet.com.