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MonoSol Rx Secures 505(b)(2) Regulatory Pathway for Montelukast Sodium Oral Soluble Film

WARREN, N.J., March 30, 2011 /PRNewswire/ -- 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."

About MonoSol Rx

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in films. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company's leadership in film drug delivery is supported by strong intellectual property, a portfolio of commercialized prescription and over-the-counter (OTC) drug products, a pipeline of prescription formulations based on PharmFilm® technology, and two recent FDA approvals - Zuplenz® (ondansetron) oral soluble film 4 mg and 8 mg, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone®  (buprenorphine and naloxone) sublingual film 2 mg/0.5 mg and 8 mg/2 mg CIII, the first sublingual film product for the treatment of opioid dependence.  

MonoSol Rx's commercialization strategy for all PharmFilm® products is to partner with the innovator or other specialty pharma companies that can sell-in and manage product sales and marketing.  PharmFilm® is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and orally disintegrating tablets (ODTs). For existing and future partners, PharmFilm® formulations can also represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration.  For press releases and other company information visit


MonoSol Rx:
Keith Kendall
Executive Vice President
(732) 564-5000

The Ruth Group (on behalf of MonoSol Rx)
Jason Rando (media)
(646) 536-7025

Joshua Drumm (investors)
(646) 536-7006

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