The FDA has given the go-ahead for an opioid-dependence drug, Suboxone, to hit the market after October. The drug was developed jointly by MonoSol Rx, which markets PharmFilm drug delivery technology, and Reckitt Benckiser Pharmaceuticals.
The news is part of New Jersey-based MonoSol Rx's continuing mission to take existing drugs and formulate thin-film, postage-stamp-sized versions of them that dissolve under the tongue--sort of a high-tech version of the breath strips one can buy at your local convenience store. We previously reported on a joint patent filed between MonoSol and Midatech for a dissolving thin-film alternative to delivery of nanoparticles for diabetes treatment.
This is also the second U.S. marketing authorization for a prescription product based on PharmFilm technology. The first was the July approval of the anti-nausea drug Zuplenz oral soluble film. MonoSol's PharmFilm delivers medication in a way that is easy to swallow without water, especially for pediatric, geriatric and neurodegenerative disease patients for whom proper dosing can be difficult. The films dissolve under the tongue or against the cheek and deliver medication in a highly uniform way, according to MonoSol.
Reckitt Benckiser spokeswoman Harriet Ullman tells In-PharmaTechnologist that the product is clinically interchangeable with Suboxone tablets and that clinical trial patients preferred the film formulation. Reckitt will market the drug to physicians across the U.S. as part of a complete treatment plan for opioid dependence that includes counseling.
The product also will come in a child-resistant pouch--an important feature, as a quick-dissolving film could present more of a temptation for children.