FDA warns Alkermes over Vivitrol misbranding

Ireland-incorporated biotech Alkermes (Nasdaq: ALKS) saw its shares down almost 3% at $20.93 yesterday after it received a sharp rebuke from the US regulator over advertising of its opioid dependence drug.

The US Food and Drug Administration posted a  warning letter to Alkermes for misbranding the drug Vivitrol (an extended-release injection formulation of naltrexone) by omitting warnings about the most serious risks associated with the drug from promotional materials.

Vivitrol, which generated sales of $85.2 million in the last reporting quarter, is approved for the prevention of relapse to opioid dependence, following opioid detoxification and should be part of a comprehensive management program that includes psychosocial support. Known as medication-assisted treatment, the use of medications like Vivitrol, in combination with counseling and behavioral therapies, is effective in the treatment of opioid use disorder (OUD) and can help some people to sustain recovery. The warning letter was issued in relation to a print advertisement about Vivitrol. While the print advertisement contains claims and representations about the drug’s benefits, it fails to adequately communicate important warnings and precautions listed in the product labeling, including vulnerability to opioid overdose, a potentially fatal risk, said the FDA.