An FDA advisory panel voted to recommend approval of Danish biotech Egalet’s ($EGLT) abuse-deterrent pain medication Arymo ER (morphine sulfate).
In its meeting, the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted that if Arymo is approved by the regulatory agency, it must be labeled as an abuse-deterrent product by the oral route, nasal route and intravenous route of abuse.
The drug uses Egalet’s Guardian technology to help patients manage pain that requires daily, long-term opioid treatment when alternative treatments are insufficient, the company said.
"We believe Arymo can offer patients, when appropriate, effective pain relief and can deter potential abuse,” Bob Radie, president and CEO of Egalet, said in a statement. “We will continue to work closely with the FDA over the next few months to bring this product to the market."
A decision by the regulatory on approval of the drug is expected in October. Drug companies have been responding to the epidemic of opioid abuse and rising number of overdose deaths in the U.S. in recent years with medications that are less likely to be abused, as well as drugs that help counteract overdose deaths.
Last November, the FDA approved Adapt Pharma's Narcan nasal spray, which became the first noninjectable treatment for opioid overdose emergencies. Narcan administers a 4-mg dose of naloxone in one nasal spray of 0.1 ml of solution.
- here’s the release
Danish biotech Egalet pitches $69M IPO on Nasdaq
Adapt Pharma earns FDA approval for opiod overdose intranasal spray
AZ faces market-making task to capitalize on Movantik's edge in OIC