Exciting news from Aquestive Therapeutics! They just got the green light from the FDA for Libervant™ (diazepam) Buccal Film. It’s a big deal because it’s the first oral rescue treatment given the thumbs up for tackling seizure clusters in kids aged 2 to 5.
Daniel Barber, the CEO of Aquestive, couldn’t hide his excitement. He mentioned how patients have been eagerly waiting for Libervant, and now it’s finally here to make a difference in their lives. They’re already accepting and filling prescriptions (except for Medicaid ones) and plan to ramp up distribution soon.
This approval marks Aquestive’s fourth win with the FDA since 2018, which is pretty impressive. They’re also making good progress with their Anaphylm program, with an NDA submission expected by the end of 2024.
Now, what makes Libervant special is how it delivers diazepam in a whole new way. Instead of popping a pill, it’s a thin film that you stick inside the cheek. It dissolves quickly, giving a consistent dose of diazepam to help during seizure emergencies. And it’s been shown to be easy to use, even for little ones as young as 2 years old.
Michael Rogawski, a neurology and pharmacology expert from the University of California, Davis, thinks it’s a game-changer. He highlighted how convenient it is to carry around, so kids can get the help they need wherever they are.
Overall, it’s a win for both Aquestive and the patients they serve. Great job, team!
Oh, and if you’re interested, they’re hosting a conference call for investors on April 29 at 8:00 a.m. ET to share more details.
