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New dosages of sublingual form of buprenorphine win approval

August 20, 2012
by Gary Enos
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 Two new dosages of the sublingual form of the medication buprenorphine (Suboxone) for the treatment of opioid dependence soon will be available, with the Aug. 20 announcement of approval of 4 mg and 12 mg doses by the Food and Drug Administration (FDA).

Suboxone sublingual film in doses of 2 mg and 8 mg has been available since federal approval of those doses in 2010. Reckitt Benckiser Pharmaceuticals Inc., maker of the combination of buprenorphine and naloxone that is marketed as Suboxone, expects to have the two new doses accessible to prescribers later this year.

A news release from the company stated that the multiple doses of individually wrapped sublingual film will afford physicians more customizable options for patient treatment while also continuing to provide safeguards against children’s accidental use of inappropriately stored medication.

Reckitt Benckiser’s labeling information for Suboxone sublingual film states that, as with Suboxone in pill form, the medication is best used in combination with counseling and psychosocial support. Some adverse events have been commonly observed with sublingual administration of Suboxone; these include numb mouth, redness of the mouth and sore tongue.

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