Within a month, prescribers of the opioid dependence medication Suboxone will have the option of prescribing a second formulation of the drug that could improve patient compliance. Reckitt Benckiser Pharmaceuticals, Inc. announced Aug. 31 it had received federal approval to market a sublingual film that patients in clinical trials preferred to Suboxone sublingual tablets.
The new formulation of the medication that combines buprenorphine and naloxone was developed under an exclusive agreement between Reckitt Benckiser and MonoSol Rx, a company whose PharmFilm technology was first authorized for prescription use with the July approval of the anti-nausea medication Zuplenz (ondansetron) by the Food and Drug Administration (FDA).
“During clinical studies, Suboxone sublingual film was shown to be faster dissolving than Suboxone sublingual tablets,” Reckitt Benckiser president Shaun Thaxter said in a statement announcing the film’s approval. “Because of the faster dissolution and the taste profile, patients preferred the film.”
Both formulations taken under the tongue now will be available for maintenance treatment of opioid dependence. The manufacturer emphasizes that Suboxone should be used as one element of a comprehensive addiction treatment program that includes counseling and psychosocial support.
Officials with MonoSol Rx state that the two drug approvals they have received over the past couple of months confirm federal regulators’ acceptance of their technology as a viable drug delivery option. They have developed PharmFilm in an effort to improve the convenience and compliance associated with new and existing medications.
The sublingual film will be packaged in individual doses using child-resistant pouches. Warnings associated with the medication include that it should always be kept out of the reach of children, who can suffer severe respiratory depression if they take the medication.