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news.MonoSol Rx has completed the pilot product development for its thin film formulation of escitalopram oxalate, a selective serotonin reuptake inhibitor.
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Escitalopram oxalate is indicated for depression and generalized anxiety disorders and is marketed under the brand name Lexapro.
Based on product development results, the company is preparing to initiate bioequivalence trials to support marketing submissions in the US and Europe.
The company is currently exploring potential partnerships to market its thin film formulation of escitalopram oxalate and expects to solidify an agreement prior to global regulatory submissions. The PharmFilm escitalopram oxalate product should be available for marketing ahead of generic entrants expected in 2012, when Lexapro loses patent exclusivity in the US.
Mark Schobel, president and CEO of MonoSol Rx, said: “Our completion of prototype development has advanced our thin film escitalopram oxalate product to the clinical investigation stage of the project.
“Our proprietary PharmFilm technology delivers thin-film drug products designed to offer significant patient benefits over other currently marketed prescription drug products and will help ensure that patients receive the appropriate dose in all treatment settings.”