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MonoSolRx LLC Receives FDA Orphan Drug Designation For Diazepam Buccal Soluble Film To Treat Acute Repetitive Seizures



12/1/2016 9:13:09 AM

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PIVOTAL TRIAL EXPECTED TO INITIATE IN EARLY 2017

WARREN, N.J., November 30, 2016 – MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Diazepam Buccal Soluble Film (Diazepam BSF) for the treatment of Acute Repetitive Seizures (ARS). The Company plans to initiate a pivotal study of Diazepam BSF in adults in early 2017.

MonoSol Rx believes that Diazepam BSF will offer ARS sufferers a better treatment option when compared to the currently marketed product, Diastat® rectal gel. Diazepam BSF is based on MonoSol Rx’s proprietary and patented PharmFilm® technology. Diazepam is a benzodiazepine that is also used to treat a variety of indications, including anxiety disorders, alcohol withdrawal symptoms, muscle spasms and seizures.

“Securing Orphan Drug Designation from the FDA’s Office of Orphan Products Development is a significant milestone for MonoSol Rx,” said Keith Kendall, CEO of MonoSol Rx. “Diazepam is well established as an effective treatment for ARS, but oral administration is challenging given the likelihood that a patient experiencing a seizure will have difficulty swallowing. PharmFilm-based Diazepam BSF may be able to address the challenges of oral administration through adhesion to the inside of the cheek. We believe that the unique delivery method of Diazepam BSF represents an attractive alternative to the current standard of care, a rectally-administered Diazepam gel. We have identified a clear clinical path forward for our Diazepam BSF with the FDA, with multiple clinical studies starting in early 2017, and are excited by the prospect of bringing this novel therapy to patients in need.”

Under the U.S. Orphan Drug Act, the FDA’s Office of Orphan Products Development provides special status and incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the U.S. With this designation, Diazepam BSF is eligible for seven years of marketing exclusivity following potential FDA approval. Additionally, Orphan Drug Designation provides incentives including federal grants, prioritized consultation by the FDA on clinical studies, tax credits and a waiver of PDUFA filing fees. The orphan designation does not alter the standard regulatory requirements, timing and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies.

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, and convenience of pharmaceutical and over-the counter products. MonoSol Rx 's leadership in film drug delivery 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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