FDA Approves Sub-lingual Treatment for Opioid Dependence

September 1, 2010

A sub-lingual film designed to treat opioid dependence was approved for marketing by the FDA.

A sub-lingual film designed to treat opioid dependence was approved for marketing by the FDA.

The film, Subxone (buprenorphine HCI/naloxone HCI dehydrate), is produced by Reckitt Benckiser Pharmaceuticals Inc., a partner of MonoSol Rx, developers of PharmFilm technology.

PharmFilm specializes in film pharmaceutical products. In July, MonoSol Rx’s product Zulenz (ondanstron) was approved as well.

Suboxone sublingual film delivers a quick-dissolving therapeutic dose of buprenorphine, a partial agonist, and naloxone, an opioid antagonist. It is rapidly absorbed under the tongue to ensure compliance.