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A new tablet formulation of buprenorphine-naloxone wins FDA approval

July 5, 2013
by Gary A. Enos, Editor
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Options for administration of the buprenorphine-naloxone medication combination for the treatment of opioid dependence continue to grow. Just months after the emergence of generic sublingual tablet alternatives to Reckitt Benckiser’s Suboxone, and that company’s transition to marketing sublingual film only, the Food and Drug Administration (FDA) has approved a new tablet version of the medication.

Pharmaceutical company Orexo U.S., Inc. announced July 5 that the FDA has approved a buprenorphine-naloxone product that will be sold as Zubsolv. This formulation also is taken under the patient’s tongue, but according to company officials it features a fast dissolve time, a smaller tablet size and a menthol flavor.

According to an Orexo spokesperson, data presented this year at the annual conference of the American Society of Addiction Medicine (ASAM) found that patients tended to prefer this new formulation over that of Suboxone tablets or film, a factor that the company believes could play a role in improving medication compliance.

The company added in a news release that Zubsolv will deliver a greater quantity of active ingredient into the bloodstream, thus allowing for use of a lower strength of the medication and thereby reducing diversion risk as well.     

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