FDA Accepts Riluzole Oral Film New Drug Application for ALS


Riluzole oral film is a novel formulation of riluzole, which is an adjuvant therapy for amyotrophic lateral sclerosis.

Aquestive Therapeutics is seeking FDA approval for their novel formulation of riluzole, riluzole oral film (ROF), which is an adjuvant therapy for amyotrophic lateral sclerosis (ALS), according to a press release. Officials with the FDA have accepted the company’s New Drug Application (NDA) for the product, which Aquestive intends to market under the brand name Exservan.

ALS is a progressive neurodegenerative disease that affects the nerve cells in the brain and spinal cord, leading to atrophy of the muscles. Patients with the disease experience muscle weakness from the degeneration of motor neurons, which typically affects the arms and legs, speech, swallowing, and breathing.

To support its NDA, the development of ROF with PharmFilm technology included studies demonstrating the product’s pharmacokinetic bioequivalence to the reference listed drug, riluzole oral formulation (Rilutek). Additional studies assessed patients’ ability to swallow ROF as well.

Riluzole oral formulation was approved as the first drug for the treatment of ALS designed to slow progression of the disease. Riluzole has been repeatedly shown to modulate glutamate neurotransmission by inhibiting both glutamate release and postsynaptic glutamate receptor signaling.

In September 2018, the FDA approved riluzole oral suspension (Tigultik, ITF Pharma) for patients with ALS, offering the first easy-to-swallow thickened riluzole liquid. If approved, ROF will offer an additional option to ease administration for patients with difficulty swallowing.

“Oral films offer great promise to patients who face difficulty swallowing or administering traditional forms of administration,” Daniel Barber, chief strategy and development officer of Aquestive, said in a statement. “In addition to Exservan, we are also focused on advancing Libervant toward an NDA filing this year. We believe these innovations are important and can help patients interact consistently and compliantly with their medication.”

Aquestive’s investigational diazepam buccal film (Libervant) is a novel oral formulation of diazepam in development for the management of selected patients with refractory epilepsy who require intermittent use of diazepam to control episodes of increased seizure activity. The product is administered as a small, thin film strip for placement inside the cheek.

The Prescription Drug User Fee Act goal date for ROF is November 30, 2019, according to the release.


Aquestive Therapeutics Announces US Food and Drug Administration (FDA) Acceptance of New Drug Application for Riluzole Oral Film for Treatment of ALS [news release]. Aquestive Therapeutics. https://aquestive.com/single-news?post=7156. Accessed April 16, 2019.

Aquestive Therapeutics Announces Late-Breaking Findings of its Investigational Diazepam Buccal Film (DBF) Formulation in Adults with Epilepsy [news release]. Aquestive Therapeutics. https://aquestive.com/single-news?post=6861. Accessed April 16, 2019.

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