FDA Pharmaceutical Approval: Suboxone
According to ClinicaSpace, MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in film pharmaceutical products, today announced that its partner, Reckitt Benckiser Pharmaceuticals Inc., a wholly-owned subsidiary of Reckitt Benckiser Group plc (LSE: RB), has received approval from the U.S. Food and Drug Administration (FDA) to market Suboxone® (buprenorphine HCl/naloxone HCl dihydrate) sublingual film for the treatment of opioid dependence.
This is the second U.S. marketing authorization for a prescription product based on MonoSol Rx’s PharmFilm® technology, closely following the July 2010 FDA approval of the anti-emetic Zuplenz® (ondansetron) oral soluble film.
Suboxone® sublingual film delivers a convenient, quick-dissolving therapeutic dose of buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist. The drugs rapidly absorb under the tongue to ensure compliance.
A. Mark Schobel, President and CEO of MonoSol Rx, stated, “We are very pleased to announce the approval of Suboxone® sublingual film and disclose our important relationship with Reckitt Benckiser. Following the FDA approvals of Suboxone® sublingual film and Zuplenz® oral soluble film, both within the past two months, the agency has clearly accepted our proprietary PharmFilm® technology as a viable prescription drug dosage form.