Reckitt Benckiser Pharmaceuticals Inc. announces that it has received approval from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) to manufacture and market Suboxone sublingual film. Suboxone sublingual film has been developed through an exclusive agreement with MonoSol Rx, utilising its proprietary PharmFilm technology, to deliver the opioid dependence treatment Suboxone in a fast-dissolving sublingual film.

Suboxone sublingual film is indicated for maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counselling and psychosocial support. Prescription use of this product is limited to physicians certified under the Drug Addiction Treatment Act, 2000.

Suboxone sublingual film will be available from early October 2010 to patients in the same doses as currently offered by Suboxone (buprenorphine and naloxone) sublingual tablets C-III. A Risk Evaluation and Mitigation Strategy (REMS) program is being implemented as part of the FDA requirements to ensure that the benefits of treatment with Suboxone sublingual film outweigh the potential risks, particularly risks of accidental overdose, misuse and abuse.

Commenting on the FDA’s approval, Shaun Thaxter, president of Reckitt Benckiser Pharmaceuticals Inc. said: “The development of Suboxone sublingual film through our exclusive agreement with MonoSol Rx reinforces our commitment to our opioid dependence therapy franchise and to its development. During clinical studies, Suboxone sublingual film was shown to be faster dissolving than Suboxone sublingual tablets. Because of the faster dissolution and the taste profile, patients preferred the film. Each individual dose of Suboxone sublingual film will come in a child-resistant pouch.

Our partnership with MonoSol Rx represents a strategic business opportunity which will contribute to the longevity of Suboxone in the US.”

Reckitt Benckiser Pharmaceuticals Inc. is a speciality pharmaceutical company that manufactures and markets Suboxone (buprenorphine and naloxone [2 mg/0.5 mg and 8 mg/2 mg]) C-III sublingual tablets and Subutex (buprenorphine [2 mg and 8 mg]) C-III sublingual tablets, formulations of buprenorphine used to treat opioid dependence.

MonoSol Rx, LLC is a speciality pharmaceutical company leveraging its proprietary PharmFilm technology to deliver drugs in quick dissolving films. PharmFilm is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs.