US FDA approves oral film formulation for treatment of rare seizure syndrome

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/ Iiado Frazao)
(Image: Getty/ Iiado Frazao)

Related tags: formulation, film, FDA approval, Fda

FDA approves first and only oral film formulation drug for seizures associated with Lennox-Gastaut syndrome.

Aquestive Therapeutics’ drug Sympazan (clobazam), an oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome​ (LGS) in patients 2 years of age or older, was approved by the US Food and Drug Administration (FDA) – offering a new treatment option for patients. Previously, the only other FDA approved version of clobazam was offered as a tablet or an oral suspension form.

Sympazan’s formulation is based on Aquestive’s PharmFilm technology. The oral film formulation was tested against oral tablet formulation in multiple pharmacokinetic studies and demonstrated bioequivalence to tablets, with comparable safety profiles.

A spokesperson for Aquestive told us that the company’s manufacturing facilities have produced more than 1 billion doses of medicine since 2014 using the PharmFilm technology. Sympazan will be produced at Aquestive’s facilities using the company’s proprietary patents.

According to Aquestive, patients with LGS, a severe form of epilepsy beginning in early childhood, often have a hard time swallowing pills or large volume of suspensions. The difficulties associated with drug administration can lead to inconsistent dosing and increasing challenges for patients and caretakers.

A spokesperson from Aquestive explained to us, “Sympazan is purposefully designed to meet the needs of patients with Lennox-Gastaut Syndrome​.”

“[Sympazan is] a lingual film that adheres to the tongue and quickly dissolves providing a simpler and more reliable way to dose the medication,”​ the spokesperson added.

The company stated that oral suspension and tablet formulations may cause patients to become combative or resistant to treatment.

The spokesperson told us that the drug belongs to a subclass of benzodiazepines that produce anticonvulsant effects while causing as much sedation as other benzodiazepines.

Plans to commercialize Sympazan in November have been expressed by the company. Aquestive has stated that it has been in contact with Ashfield Healthcare that specializes in commercialization services to bring the drug to pediatric neurologists and epileptologists.

CBD and LGS

Recently, cannabidiol (CBD) has been developed as a treatment for LGS, as well as Dravet Syndrome.

The FDA gave marketing approval to Epidiolex​, the CBD treatment created by GW Pharmaceuticals. However, the company had to get further approval from the Drug Enforcement Administration​ (DEA) to market the product.

The DEA decided to mark the treatment as a schedule V drug on October 1, 2018. At that time the Epilepsy Foundation gave a statement remarking that “[the drug] is a tremendous milestone for some of these most vulnerable individuals who now may have access and hoping of gaining better seizure control.”

It has since been launched in the US​ and is currently awaiting a decision from the European Union regarding marketing authorization.

The average list price​ for Epidiolex is $32,500 (28,327) annually but it is anticipated to be covered by most insurance plans. 

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