Aquestive’s oral film ALS medication approved by FDA

By Maggie Lynch

- Last updated on GMT

(Image: Getty/Anusuron Nakdee)
(Image: Getty/Anusuron Nakdee)

Related tags FDA approval ALS Drug delivery Drug delivery technology film

US FDA approves Aquestive’s oral film medication for the treatment of ALS using its PharmFilm technology.

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.

Related news

Show more

Related products

show more

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Pulmonary Delivery of Orally Inhaled Therapeutics

Pulmonary Delivery of Orally Inhaled Therapeutics

Content provided by Catalent Pharma Solutions | 19-Oct-2023 | Business Advice

New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small...

Related suppliers

Follow us

Products

View more

Webinars