(RTTNews) - Aquestive Therapeutics, Inc. (AQST), a pharmaceutical company focused on delivering innovative medicines, announced that the FDA has granted Orphan Drug Exclusivity to Libervant (diazepam) Buccal Film for the acute treatment of seizure clusters in pediatric patients aged 2 to 5 years.
Libervant, the first and only FDA-approved orally administered rescue therapy for this indication, offers an important non-invasive treatment option for children with epilepsy experiencing frequent, acute repetitive seizures that differ from their usual seizure pattern.
The Orphan Drug Exclusivity grants seven years of market exclusivity in the U.S. for Libervant, with exclusivity extending until April 2031.
This approval follows the FDA's April 2024 approval of Libervant for the treatment of seizure clusters in this patient group, recognizing its major contribution to patient care over the traditional rectal route of administration by offering greater ease of use.
Libervant's approval for the 2 to 5-year-old patient population follows the initial Orphan Drug Designation granted by the FDA in 2016 and is a significant step forward for Aquestive in expanding its portfolio of products aimed at improving patient care.
Libervant is a buccally administered film formulation of diazepam, providing a critical tool for seizure management in pediatric epilepsy patients. It serves as a key alternative to device-based treatments such as rectal gels and nasal sprays, offering easier administration without the need for invasive procedures.
AQST closed Thursday's (Dec. 19, 2024) trading at $3.64, up 5.20%. In premarket trading, the stock is up by 2.20% at $3.72.
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