MonoSol Rx Successfully Completes Dose Proportionality Study of Diazepam Buccal Soluble Film to Treat Acute Repetitive Seizures

PIVOTAL TRIAL EXPECTED TO INITIATE IN EARLY 2017

WARREN, N.J., January 6, 2017 – MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, today announced the completion of a dose proportionality study evaluating Diazepam Buccal Soluble Film (Diazepam BSF) for the treatment of Acute Repetitive Seizures (ARS).

Diazepam BSF, based on MonoSol Rx’s proprietary and patented PharmFilm technology, is a benzodiazepine used to treat ARS, as well as a variety of other indications including anxiety disorders, alcohol withdrawal symptoms, muscle spasms and seizures. The only product currently indicated for ARS is Diastat Rectal Gel. MonoSol Rx’s Diazepam BSF could potentially be the first and only oral treatment available for ARS sufferers.

The results show that MonoSol Rx’s Diazepam BSF is linear across all dosage strengths. This compares favorably to publicly available data for other alternative diazepam dosage forms. Based on this comparison, MonoSol Rx plans to initiate a pivotal study of Diazepam BSF in adults with ARS in the first quarter of 2017.

“We are extremely excited by the results of this study, which demonstrate that the pharmacokinetic profile of Diazepam BSF is consistent across dose strengths,” said Keith Kendall, CEO of MonoSol Rx. “We believe that Diazepam BSF will be able to overcome the many challenges associated with alternate delivery methods of this molecule and offers the potential to improve outcomes for ARS patients in need. We look forward to the continued progress of our Diazepam BSF program in the coming months.”

About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm drug delivery technology to develop products that improve patient outcomes and address unmet needs.   PharmFilm can benefit patients by improving the efficacy, safety, convenience, compliance and pharmacoeconomics of pharmaceutical products. MonoSol Rx's leadership in film drug technology is supported by strong IP protection, a robust pipeline of prescription drug formulations, and two FDA-approved products — Suboxone® (buprenorphine and naloxone) sublingual film and Zuplenz® (ondansetron) oral soluble film. For press releases and other company information, visit www.monosolrx.com.

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