11/1/2019
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`Neurelis Receives FDA Orphan Drug Designation for NRL-1 for Seizures
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`Neurelis Receives FDA Orphan Drug Designation for NRL-1 in the Treatment of Acute Repetitive Seizures
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`NEURELIS RECEIVES FDA ORPHAN DRUG DESIGNATION FOR NRL-1 IN
`THE TREATMENT OF ACUTE REPETITIVE SEIZURES
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` / 22 December 2015 0 Comments (/neurelis-news/fda-orphan-drug-designation/#comments)/
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`Neurelis, Inc. ("Neurelis") today announced receipt of Orphan Drug Designation from the FDA
`for their lead program, NRL-1 (intranasal diazepam) for pediatric, adolescent, and adult
`epilepsy patients who experience acute repetitive seizures. The FDA's Orphan Drug
`Designation program provides orphan status to drugs intended for the safe and eective
`treatment of rare disorders that aect fewer than 200,000 people in the United States. This
`designation also allows Neurelis to be eligible for a seven-year period of U.S. marketing
`exclusivity upon approval of NRL-1, as well as other benets, including tax credits for clinical
`research costs and the waiver of Prescription Drug User Fee Act (PDUFA) ling fees. "We are
`pleased to have received Orphan Drug Designation from the FDA based on the potential
`clinical benet of NRL-1 to patients who experience acute repetitive seizures" stated Craig C.
`Chambliss, President and Chief Executive Ocer of Neurelis. "Pediatric, adolescent, adult
`patients and their caregivers desire an eective, reliable, and well-tolerated treatment
`alternative to either rectal diazepam or an emergency room visit. We are committed to
`bringing NRL-1 to the epilepsy community for this very purpose. This designation is an
`important milestone to achieve as we continue the clinical development program for NRL-1."
`About NRL-1
`NRL-1 (intranasal diazepam) is a proprietary formulation of diazepam, delivered via an already
`marketed nasal sprayer, being developed for the management of pediatric and adult patients
`who require intermittent use of diazepam to control bouts of acute repetitive seizure activity.
`In clinical trials, NRL-1 has demonstrated high bioavailability, low variability from dose to dose,
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`11/1/2019
`Neurelis Receives FDA Orphan Drug Designation for NRL-1 for Seizures
`and was well-tolerated. There are over 2.7 million people with epilepsy in the United States
`with approximately 200,000 new patients diagnosed each year. It is estimated that between
`30% and 40% of these patients are uncontrolled on oral therapy and are at-risk for acute
`breakthrough seizures. Studies have shown that prolonged or repetitive seizures can cause
`neurological damage and dramatically increase the risk of changes in neuropsychological
`function or even death.
`About Neurelis
`Neurelis, Inc. is a privately-held San Diego-based specialty pharmaceutical company organized
`to license, develop, and commercialize product candidates for epilepsy and the broader
`central nervous system (CNS) market. Neurelis leverages expertise in the development and
`commercialization of CNS compounds and strong relationships with leading researchers and
`clinicians in these markets to advance unique product candidates to address signicant unmet
`medical needs.
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`© Neurelis, Inc. 2019. All rights reserved.
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