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Monosol Rx Receives FDA Acceptance of Investigational New Drug Application

15-Jan-2017 | Source : MonoSol Rx | Visits : 4983
WARREN, N.J. - MonoSol Rx, a specialty pharmaceutical company leveraging its PharmFilm® drug delivery technology to improve patient outcomes and to address unmet needs, announced in a press release that the US 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.”

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