Aquestive Therapeutics (AQST) said Thursday that its Libervant Buccal Film has received seven years of orphan drug exclusivity from the US Food and Drug Administration to treat seizure clusters in patients with epilepsy ages two to five.
The regulator's decision was based on the assessment that Libervant's buccal route of administration offers a "major contribution" to patient care in comparison to the rectal route of administration regarding the ease of use, the company added.
Libervant Buccal Film obtained the FDA's approval in April.
Shares of the company were up more than 3% in recent Thursday trading.
Price: 3.59, Change: +0.13, Percent Change: +3.64
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