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FDA Approves Maintenance Drug to Treat Opioid Dependence

Pills in a prescription bottle (


Orexo AB, a pharmaceutical company in Uppsala, Sweden says it received approval from the U.S. Food and Drug Administration to market in the U.S. its drug Zubsolv for the treatment of opioid dependence, such as from prescription pain killers. FDA, says the company, approved the drug as a maintenance treatment — a substitute for addictive substances — as part of a comprehensive counseling and support program.

A report last year from the Centers for Disease Control and Prevention calls prescription drug abuse “the fastest growing drug problem in the United States,” and labels the problem of prescription drug overdoses an epidemic. Since 2003, says the CDC, “more overdose deaths have involved opioid analgesics than heroin and cocaine combined.” The CDC report says opioid misuse and overdose death are highest among men, and those age 20 to 64, although a new CDC study says the rate of prescription pain killer overdoses is now increasing faster for women than men.

Zubsolv, says the company, consists of the compounds buprenorphine and naloxone that act to prevent withdrawal symptoms after a patient stops taking the opioids, and blocks the high induced from inappropriate intravenous injections of a dissolved tablet. The same compounds are found in the current leading opioid maintenance drug — Suboxone, made by Reckitt Benckiser Pharmaceuticals — and like Suboxone, Zubsolv is a tablet dissolved under the tongue. (Suboxone is also available as a film that dissolves under the tongue.)

Orexo says Zubsolv dissolves faster and enters the blood stream faster than Suboxone. Zubsolv tablets are also smaller, says the company, and have a better taste than the Suboxone products. Orexo cites data from clinical trials conducted last year showing 8 to 9 in 10 subjects preferring Zubsolv to competing products.

The company plans to bring the product to market in September. Orexo estimates the value of the market at more than $2 billion, with 5 million Americans dependent on opioids and less than 20 percent receiving adequate treatment.

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