FDA approves generic form of drug used to treat opioid addiction


(AP) – U.S. regulators have approved the first generic version of an under-the-tongue film for treating opioid addiction.

The Food and Drug Administration on Thursday approved a generic version of Suboxone, a film strip that dissolves under the tongue. Used daily, it reduces withdrawal symptoms, cravings for opioids and the high from abusing them.

The medication combines buprenorphine and naloxone. It’s used along with counseling and other behavioral therapy.

Almost 250 patients at Shoreline Behavioral Health are using suboxone to overcome opioid addiction, according to Executive Director John Coffin. That’s about two thirds of the total population. He called suboxone a “miracle drug”. 

“We had to create a separate treatment group for folks who are on the medication for treatment because they progress so much faster,” he said.

Doctors prescribe suboxone in several forms including pills and as an injectable, which vary in price. Coffin said Shoreline patients usually receive the pills or oral strips. 

“In most cases, the cheapest because it’s hugely expensive,” he said.

Brand-name Suboxone film costs about $200 a month without insurance, but Coffin said the generic could cost half that. HE said he’s optimistic the generic could help more addicts.

“Probably the biggest reason people may stop suboxone, even though it may be life threatening to stop it, will be because they can’t afford it.,” he said. He added the strips are “a faster delivery system so it will more quickly cover cravings.” 

Coffin hopes the FDA approves more generic forms of suboxone, especially the injectable form, which he said can cost up to $1,500 a shot.

“I think the big difference is, without it, people return to use and drop out. And then we don’t see them again unless you read about them as a statistic.”

The generic version will be sold by partners Mylan N.V. and Dr. Reddy’s Laboratories SA. They didn’t immediately respond to questions about when their version will be available or what it will cost.

The FDA said the approval was aimed at making the treatment available to more people.

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