The US Food and Drug Administration (FDA) accepted Aquestive Therapeutics’ new drug application (NDA) for the investigational product riluzole oral film (ROF) for the treatment of amyotrophic lateral sclerosis (ALS).
ROF is an adjunctive therapy that the company intends to market under the brand name Exservan while exploring commercial opportunities for the drug in the US and other markets. The drug received an orphan drug designation by the FDA in January 2018.
Studies of Exservan, which uses PharmFilm technology for oral film administration, demonstrated the product’s pharmacokinetic bioequivalence to the reference listed drug, Rilutek.
According to a spokesperson for Aquestive, riluzole inhibits glutamate and protects nerve cells from excess glutamate neurotransmission that occurs with ALS.
The Aquestive spokesperson told us, “ROF is delivered on a postage stamp-sized film that dissolves in the mouth.”
Aquestive believes that, with this method of drug delivery, patient adherence to the medication will increase, as ALS can cause difficult swallowing or administering traditional forms of medication.
ROF will be manufactured using Aquestive’s PharmFilm technology and formulation in house. The spokesperson said that the PharmFilm technology has been used to deliver, ‘billions of doses’ to patients worldwide.