MonoSol aims for asthma market with thin film

MonoSol Rx, a company that specializes in developing fast-dissolving thin-film versions of existing drugs, is taking aim at what it's calling the $12.7 billion global asthma market. The company is developing an oral soluble film of Montelukast Sodium, the active pharmaceutical ingredient in Singulair, an asthma and allergy treatment that generated sales of $4.7 billion in 2009. Perhaps a more important fact, though is this: Singulair faces patent expiration in 2012, which could possibly open up opportunities for MonoSol's thin-film formula. MonoSol reports another step along the way toward approval, with a pre-investigational new drug meeting with the FDA, where the regulatory agency decided that the Montelukast thin film's registration dossier will be primarily based on pharmacokinetic studies, without the need for clinical efficacy trials. Release

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