MonoSol Rx Receives FDA Acceptance of Investigational New Drug Application for Riluzole Oral Soluble Film to Treat Amyotrophic Lateral Sclerosis

WARREN, N.J., January 4, 2017 – 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 accepted its Investigational New Drug (IND) Application for Riluzole Oral Soluble Film (Riluzole OSF) for the treatment of Amyotrophic Lateral Sclerosis (“ALS” or “Lou Gehrig’s Disease”).

The accepted IND outlines MonoSol Rx’s clinical development plans for Riluzole OSF for the treatment of ALS. Riluzole is a glutamine blocker currently available in a tablet formulation. It has been shown to delay the onset of ventilator dependence or tracheostomy in select ALS patients, and may increase survival by two to three months. Its use has also been studied in mood and anxiety disorders as well as Alzheimer’s Disease.

“ALS is a highly debilitating neurodegenerative disease that has a tremendous impact on patients’ and caregivers’ lives. Progressive difficulties in swallowing is a well-known characteristic of this disease state.  We believe that Riluzole OSF may provide significant advantages over the current routes of administration,” said Keith Kendall, CEO of MonoSol Rx. “We are pleased that the FDA has accepted our IND and look forward to initiating our pivotal pharmacokinetic clinical study for Riluzole OSF.”

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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