Engage Therapeutics, a small biopharmaceutical company out of Summit, NJ, is testing a new hand-held inhalable device, Staccato Alprazolam, to be the first truly fast-acting, non-invasive seizure rescue treatment that could potentially stop a current, active seizure with just one breath.
With 3.4 million people in the U.S. with epilepsy and over 50 million people diagnosed worldwide, epilepsy is one of the world’s most common neurologic diseases. In the United States alone, one-third of those with epilepsy are living with uncontrollable seizures because no available treatment works for them. “For individuals with epilepsy that have a predictable seizure pattern, currently available rescue treatments can only address the prevention of seizure activity once the first seizure ends, but Staccato Alprazolam has the potential to be the first and only product that can abort an active seizure,” according to the company’s CEO, Greg Mayes, whose son has epilepsy. This small, easy-to-use hand-held device is in the REST (Rapid Epileptic Seizure Termination) category of products, testing the use of a fast-acting FDA-approved delivery system with FDA-approved alprazolam for the immediate cessation of active and acute epileptic seizures.
“Many patients with epilepsy live with the fear that a seizure may occur at any moment, highlighting the need for a rescue medication that could give patients the confidence that a seizure could be rapidly aborted,” notes Dr. Jaqueline French, the study’s principal investigator and professor in the Department of Neurology at NYU Langone Health, in the Comprehensive Epilepsy Center, and founder/director of the Epilepsy Study Consortium.
Staccato alprazolam demonstrated reduction of seizure-like activity in a photosensitivity model in a Phase 2a proof of concept study. The open-label portion of the Phase 2b study has been successfully completed, and Dr. French will be presenting the findings at the American Academy of Neurology Annual Meeting this May 2019. Engage is currently recruiting adult patients (18 years old+) who experience a predictable pattern of focal or generalized epileptic seizures in the randomized portion of the muliti-national Phase 2b clinical trial, with over 45 sites in the U.S., Australia, Canada and Jamaica. Please visit www.EngageTherapeutics.com for more information, or www.epilepsyhealthstudy.com to see if you or your loved one is eligible.