Exservan, Riluzole in Dissolving Oral Film Form, Approved by FDA

A dissolving oral film form of riluzole, called Exservan and able to be taken by amyotrophic lateral sclerosis (ALS) patients without a need for water, has been approved by the U.S. Food and Drug Administration (FDA).

Riluzole was the first ALS treatment, approved by the FDA over two decades ago. Its exact mechanism of action isn’t fully understood, but it appears to have a number of effects on neurons, including blocking certain receptors that are associated with neural damage.

Strong evidence supports this medication helping ALS patients to live longer, and studies suggest that riluzole is most effective here in those with more advanced disease.

Riluzole is approved as a pill sold under the brand name Rilutek, with generic versions also available), and in a liquid form under the brand name Tiglutik.

The novelty of Exservan, developed by Aquestive Therapeutics, is the ease of its administration. Exservan consists of a thin film that is placed on the tongue (lingual delivery). It dissolves and releases its active ingredient, riluzole, to be absorbed by the body in much the same way a pill or capsule would be.

Importantly, Exservan can easily be taken without water or other liquids, easing the therapy’s delivery to ALS patients who have difficulty swallowing — a common disease symptom.

According to its FDA label, Exservan comes as a 50 mg riluzole dose on an orange film and is recommended to be taken twice a day, at least one hour before or two hours after a meal. This film adheres to the top of the tongue and dissolves, allowing the medication to be swallowed with saliva.

It was developed using Aquestive’s PharmFilm technology, which, according to the company, optimizes the way treatments can be given for ease of use and better adherence.

Previous clinical trials demonstrated that Exservan had an equivalent pharmacokinetics profile (what happens to the drug once in the body) to Rilutek, as well as a good safety profile.

The FDA granted Exservan orphan drug status in early 2018, and announced it was reviewing a request for approval of this new formulation in April 2019. An FDA decision was expected on Nov. 30, but came days earlier.

“We received full FDA approval for Exservan in advance of our PDUFA action date. We appreciate the ongoing feedback from the FDA and its early-action approval, Keith J. Kendall, the chief executive officer at Aquestive, said in a press release.

“We anticipate that Exservan, via our orally administered … dosage form, will bring meaningful treatment to patients who are diagnosed with ALS and face difficulties swallowing or administering traditional forms of medication,” Kendall added.

Aquestive previously announced that a license for the commercialization and development of Exservan in the European Union was given to Zambon Pharma. Commercialization rights for the U.S. are not yet decided, so the start of its availability on the U.S. market is not known.

“We are continuing the dialogue with potential licensees for the US commercial rights,” Kendall said.