LibervantTM

A meaningful contribution to improved patient care

The FDA has granted tentative approval of LibervantTM (diazepam buccal film). Aquestive is prepared to commercially launch Libervant, if approved for U.S. market access. Libervant is a Diazepam Buccal Film developed as an oral rescue therapy for patients with breakthrough seizures or seizure clusters.

In the United States, 1.2 million epilepsy patients suffer from uncontrolled breakthrough seizures.1 The target population for LibervantTM* is a subset of this population. Aquestive Therapeutics recognizes the need for an oral formulation of diazepam and is leveraging its proprietary PharmFilm® technology to develop this treatment.

Advancing treatment options for epilepsy

Libervant™ is a buccally, or inside of the cheek, administered soluble film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older.

 

Aquestive developed Libervant as an alternative to the device driven, invasive, inconvenient, and difficult to administer alternatives including a rectal gel and nasal spray products, currently available for patients with refractory epilepsy.

 

Our formulation team used PharmFilm® technology to develop a diazepam formulation that is absorbed directly through the buccal mucosa. The buccal mucosa’s wide, relatively immobile, and highly permeable surface area provided the stable and controlled microenvironment needed to optimize adhesion, absorption, and onset of action.

 

*Aquestive has received conditional acceptance of the use of this trade name, which is subject to final FDA review and acceptance.

Libervant (diazepam buccal film) is an investigational drug being evaluated for use in children and adults with refractory seizures, who remain on stable regimens of antiepileptic drugs, to control bouts of increased seizure activity. The product profile, data from our trials and related statements have not been approved by the FDA.

For more information on diazepam buccal film, download our case study “Overcoming Solubility and Permeability Challenges.”

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Please complete the form below and click SEND to receive a copy of “Overcoming Solubility and Permeability Challenges,” a case study detailing the achievements made by Aquestive’s formulation team to create the diazepam buccal film.

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Please complete the form to receive a demonstration kit for our PharmFilm® technology.

  • To subscribe to receive marketing updates about our PharmFilm® technology and other products and services from Aquestive, please complete the form below. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing busdev@aquestive.com.

Please complete this form:

  • To subscribe to receive marketing updates about products and services from Aquestive Therapeutics, or to receive information about Aquestive-sponsored clinical trials, please check the box below. Please also review our privacy policy, which describes how we use and process your data. If for any reason you no longer wish to receive information on Aquestive-sponsored clinical trials, you can contact us at any time by emailing clinicaltrials@aquestive.com.

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