FDA approves two new dosage strengths of Suboxone

August 22, 2012

FDA has approved buprenorphine and naloxone (Suboxone, Reckitt Benckiser Pharmaceuticals) sublingual film in the 4-mg and 12-mg strengths for the maintenance treatment of dependence on prescription opioid painkillers and heroin.

FDA has approved buprenorphine and naloxone (Suboxone, Reckitt Benckiser Pharmaceuticals) sublingual film in the 4-mg and 12-mg strengths for the maintenance treatment of dependence on prescription opioid painkillers and heroin.

According to a company statement, Suboxone is the first opioid medication approved under DATA 2000 for the treatment of opioid dependence in an office-based setting. Suboxone also can be dispensed for take-home use, just as any other medication for other medical conditions.

Buprenorphine is a partial opioid agonist, its opioid effects are limited compared with those produced by full opioid agonists, such as oxycodone or heroin. Suboxone also contains naloxone, an opioid antagonist.

The naloxone in Suboxone is there to discourage people from dissolving the tablet and injecting it. When Suboxone is placed under the tongue, as directed, very little naloxone reaches the bloodstream, so what the patient feels are the effects of the buprenorphine. However, if naloxone is injected, it can cause a person dependent on a full opioid agonist to quickly go into withdrawal.

Suboxone at the appropriate dose may be used to reduce illicit opioid use and help patients stay in treatment by suppressing symptoms of opioid withdrawal and decreasing cravings for opioids.

The most commonly reported adverse events with Suboxone include: headache (36%, placebo 22%), withdrawal syndrome (25%, placebo 37%), pain (22%, placebo 19%), insomnia (14%, placebo 16%), nausea (15%, placebo 11%), and constipation (12%, placebo 3%).

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