Kendall, Chief Executive Officer of Aquestive. We believe that our candidate drug Libervant™ (diazepam) Buccal Film will, if approved by the FDA, further expand patient choice as the first orally administered dosage form for this patient population,” said Keith J.The sharp drop came following Aquestive's announcement it had received a CRL (complete response letter) from the FDA for its new drug application (NDA) for Libervant Buccal Film for management.Libervant is a soluble film of formulation of diazepam, is administered on the inner side of the cheek. The US FDA has accepted Aquestive Therapeutics’ NDA for Libervant (diazepam) Buccal Film for seizure clusters.Aquestive Therapeutics, Inc AQST 34.63% shares tumbled 36% to $4.9050 after the company late Friday received a Complete Response Letter from the FDA for Libervant buccal film indicating the.Aquestive Therapeutics Announces Positive Topline Results from Libervant Buccal Film Single Dose Crossover Study However, 7% of patients needed three or more AEDs to control seizures, and only one patient was referred to have a pre-surgical evaluation for refractory epilepsy.Li Zhu to Legend Biotech’s Board of Directors. Legend Biotech Corporation (NASDAQ: LEGN) ("Legend Biotech"), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced today that it has appointed Dr.Aquestive Therapeutics announced it has completed enrollment in a single dose crossover pharmacokinetic, or PK, trial for Libervant, or diazepam buccal film, which is in development for the management of select patients with refractory epilepsy who require treatment to control episodes of increased seizure activity, or "seizure clusters." The.If approved, Libervant can be carried by patients and administered without invasiveness to help lessen subsequent seizures. Libervant leverages Aquestive's proprietary PharmFilm ® technology.
Libervant is a novel formulation of diazepam administered as a thin film strip, placed inside the cheek.Home of the insider insights newsletter and the Canadian Insider Club which offers alerts and premium research. Get stock quotes, news, fundamentals and easy to read SEC and SEDI insider filings.
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Aquestive Therapeutics to Host Investor & Analyst Libervant™ (diazepam) Buccal Film Update Forum at American Epilepsy Society 2019 Annual Meeting.
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