FDA Approves New Long Acting Painkiller
/By Pat Anson, Editor
The U.S. Food and Drug Administration has approved a new extended release opioid pain medication with abuse deterrent properties.
Egalet Corporation announced Monday that the FDA has approved Arymo ER – a long-acting version of morphine -- for the management of pain severe enough to require daily, around-the-clock opioid treatment. It comes in the form of a pill that is very difficult to crush or liquefy, methods used by abusers to speed the release of an opioid into the bloodstream.
"With the majority of ER opioids in easy to abuse forms, it is important that healthcare professionals have additional treatment options like Arymo ER that are resistant to different methods of manipulation using a variety of tools," Bob Radie, president and CEO of Egalet said in a news release.
“Arymo ER has physical and chemical properties expected to make abuse by injection difficult which is important given it is the most common non-oral route of morphine abuse and the most dangerous.”
An FDA advisory panel recommended in a 18-1 vote last August that Arymo be approved. It is is the 7th opioid with abuse deterrent properties approved by the FDA. The other medications are OxyContin, Targiniq, Embeda, Hysingla, Morphabond, and Xtampza.
Arymo has been approved in three dosage strengths: 15 mg, 30 mg and 60 mg. Egalet plans to make the drug available in the first quarter of 2017.
Arymo is the first commercial product developed with Egalet’s Guardian technology, which incorporates the medication into a polymer matrix tablet to make it difficult to misuse or abuse.
“Guardian Technology results in tablets that are extremely hard, very difficult to chew, resistant to particle size reduction, and inhibit/block attempts at chemical extraction of the active pharmaceutical ingredient,” the company says in a statement on its website.
“In addition, the technology results in a viscous hydrogel on contact with liquid, making syringe-ability very difficult. These features are important to address the risk of accidental misuse (e.g., chewing) in patients with chronic pain, as well as intentional abuse using more rigorous methods of manipulation. “
The approval of abuse-deterrent medications is still somewhat controversial. Some medical professionals and anti-opioid activists say the technology does not completely prevent abuse and the drugs are still being misused by addicts.
