Reckitt Benckiser announced that the FDA has approved Suboxone (buprenorphine and naloxone) sublingual film for maintenance treatment of opioid dependence in conjunction with counseling and psychosocial support. Suboxone sublingual film uses MonoSol Rx’s proprietary PharmFilm oral soluble film technology to rapidly dissolve on the tongue without the need for water. Clinical trials showed Suboxone sublingual film to have a faster dissolution rate than Suboxone sublingual tablets.
Suboxone sublingual film is expected to be available early October 2010 in buprenorphine/naloxone 2mg/0.5mg and 8mg/2mg dosage strengths.
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