WARREN, N.J. - Aquestive Therapeutics , Inc. (NASDAQ: NASDAQ:AQST) announced that the U.S. Food and Drug Administration (FDA) has approved Libervant (diazepam) Buccal Film for the treatment of seizure clusters in pediatric epilepsy patients aged 2 to 5 years. This marks the first FDA-approved orally administered rescue product for this patient population.
Libervant, a buccal film placed inside the cheek, delivers diazepam quickly to manage acute repetitive seizure emergencies. The approval provides a new administration method compared to the existing rectal gel and nasal spray options. In 2023, over 55,000 prescriptions for seizure treatments were filled for patients in this age range, with diazepam rectal gel accounting for over 90% of these prescriptions.
Aquestive's CEO, Daniel Barber, expressed satisfaction with the FDA's decision and the company's ability to immediately accept and fill non-Medicaid prescriptions for Libervant. The company anticipates expanding its distribution capabilities in the coming weeks and months.
The FDA had previously granted tentative approval for Libervant for patients 12 years and older in August 2022, with market access contingent on the expiration of existing orphan drug exclusivity for another product in January 2027. The recent approval for the 2 to 5-year-old age group allows for immediate U.S. market access.
Moreover, Aquestive's Anaphylm (epinephrine) Sublingual Film clinical development program remains on schedule, with a New Drug Application (NDA) submission expected by the end of 2024. The company plans to provide a detailed update on Anaphylm during its first-quarter earnings call on May 8, 2024.
The news of Libervant's approval is based on a press release statement from Aquestive Therapeutics. The company has a track record of four FDA approvals since 2018 and continues to focus on developing innovative delivery technologies for complex molecules.
InvestingPro Insights
Following the recent FDA approval of Libervant, Aquestive Therapeutics, Inc. (NASDAQ: AQST) is poised to make significant strides in the pediatric epilepsy market. With a market capitalization of $370.53 million, Aquestive shows potential for growth, especially with the introduction of new treatment methods like Libervant.
Despite a challenging financial outlook with a negative P/E ratio of -31.68 for the last twelve months as of Q4 2023, the company has demonstrated a strong return over the last three months, with a price total return of 65.45%. Moreover, the last six months have seen a large price uptick, with a total return of 186.62%.
InvestingPro Tips highlight that while analysts do not anticipate Aquestive will be profitable this year, the company operates with a moderate level of debt and liquid assets that exceed short-term obligations. This financial stability could be crucial as Aquestive works to expand its market share with Libervant.
Furthermore, the company's stock price movements have been quite volatile, which could present opportunities for investors with a higher risk tolerance. For those considering an investment in Aquestive, it's worth noting that the company does not pay a dividend to shareholders, which may influence investment strategies focused on income generation.
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