MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in proprietary pharmaceutical film products, today announced that it held a pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of Montelukast Sodium Oral Soluble Film (OSF) under a 505(b)(2) pathway. The registration dossier of Montelukast Sodium OSF will be primarily based on pharmacokinetic studies, without the need for clinical efficacy trials.
Montelukast is the active pharmaceutical ingredient in SINGULAIR, an asthma and allergy treatment that generated full-year worldwide sales of $4.7 billion in 2009 and faces patent expiration in 2012. Montelukast Sodium OSF dissolves within a few seconds when placed on the tongue to provide a complete dose of medication. SINGULAIR is currently approved in a variety of formulations to help control symptoms of asthma and for relief of symptoms of indoor and outdoor allergies, in adults and children 12 months and older.
A. Mark Schobel, President and Chief Executive Officer of MonoSol Rx, stated, "We are pleased with the positive FDA feedback on the 505(b)(2) pathway for Montelukast Sodium OSF, which has demonstrated positive results in pilot bioequivalence studies when compared to SINGULAIR. We envision Montelukast OSF as a competitive product in the $12.7 billion worldwide asthma market, particularly for pediatric patients. Montelukast Sodium OSF provides parents of young children an attractive and convenient alternative to oral granules that must initially dissolve in water, milk or formula. The OSF formulation also delivers an easy-to-take, taste-masked option for children taking the chewable tablets."
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