Aquestive’s oral film ALS medication approved by FDA

By Maggie Lynch contact

- 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

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-May-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

Related suppliers

Follow us


View more