For pediatric kids aged two to five with seizure clusters, Aquestive Therapeutics (AQST, Financials) said that the U.S. Food and Drug Administration has given seven years of orphan drug exclusivity to its medicine, Libervant (diazepam). Shares are up 6.7% on the news. In terms of simplicity of usage for patients and caregivers, the choice honors Libervant's buccal administration as a significant advance above the rectal method.
Approved for use in April 2024, Libervant is the first orally given rescue treatment for this patient population. The exclusivity spans April 2031, giving Aquestive market protection for the good throughout this month. Designed to control acute seizure events unique from a patient's normal pattern, the therapy provides a non-invasive substitute for current choices.
Originally assigned orphan drug classification for Libervant in 2016, Aquestive Orphan medication exclusivity offers financial incentives and legal benefits to help rare illness medicines be developed and commercialized. Libervant is a component of Aquestive's larger range of creative, orally delivered treatments meant for difficult medical problems.
The business said that its major priorities still include raising knowledge and access for caregivers and healthcare professionals. Emphasizing safety and simplicity of use, Libervant marks a major progress in the management of seizure episodes in young children.
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