Egalet Says FDA Saw Unintended Consequence Of IV Abuse Potential With Endo's Opana ER

The U.S. Food and Drug Administration reached a conclusion this week concerning Endo International plc - Ordinary Shares ENDP's therapy Opana ER, which is intended to treat pain severe enough to require a daily, around-the-clock, long-term opioid treatment.

An independent FDA panel found the benefits of Endo's therapy no longer outweighs the risks of abuse. Opioid abuse, overdose and addiction is a major concern across the U.S. and this prompted a panel to address Endo's Opana ER, which was first approved in 2006 and a new formulation was introduced in 2012 to deter abuse.

Effect On Egalet

Egalet Corp EGLT, a specialty pharmaceutical company that develops and manufacturers treatments for pain and other conditions, has two opioid therapies, Oxaydo and Arymo ER.

Analysts at Cantor Fitzgerald offered their take of what the FDA's decision on Endo could have on Egalet's products.

A spokesperson for Egalet told Benzinga the FDA's findings reinforced the dangers of abuse through the IV route and saw the shift from the intranasal route to IV route of abuse with Opana ER as an unintended consequence because of its unique AD properties.

"ARYMO ER has an abuse-deterrent IV claim which is important given that IV abuse is the most dangerous route of abuse," the spokesperson said. "Some of the panelists also acknowledged the importance (and existence) of more robust AD technologies and that is what is needed. We believe ARYMO ER has a robust AD profile with its increased resistance to cutting, crushing, grinding or breaking using a variety of tools, which is often the first step to getting a product into an abuseable form for alternate routes of abuse."

The spokesperson emphasized that the FDA's panel raised the concern about the most dangerous route of abuse, which is intravenous injection. On the other hand, Arymo ER has physical and chemical properties, which makes abuse by injection difficult and has gelling properties that resist passage through a syringe. As such, Egalet's therapy is "expected to deter abuse through the IV route."

See Also:

DoJ Takes Action On Insys For 'Unfair, Deceptive Marketing Practices' Of Fentanyl Drug

For Egalet, Clinical Delays Outweigh Solid Q4 And Arymo Launch