FDA panel says OK to Vivitrol for opioid dependence

An FDA panel has recommended that Vivitrol, a drug that treats alcohol dependence through a drug-delivery technology by Alkermes, also be allowed to treat addiction to opioids like heroin. The FDA's Psychopharmacologic Drugs Advisory Committee voted 12 to 1 in favor. The FDA is set to make a decision by Oct. 12.

What makes Vivitrol effective is Alkermes’ proprietary, injectable extended-release technology called Medisorb, which enables sustained releases over long periods of time. Vivitrol, for example, is injected only once a month. The company says the technology allows us it to encapsulate small molecules, peptides and proteins in microspheres made of biodegradable polymers with extended-release profiles lasting from days to months.

The Associated Press reports that some doctors already prescribe Vivitrol off-label as a treatment for opioid addiction, so if the FDA grants the new approval, sales are not going to jump right away.

- read the Alkermes release
- learn about Medisorb
- read the AP report
- and see how the company’s stock responded