Aquestive Therapeutics Receives U.S. FDA Orphan Drug Designation for Riluzole Oral Soluble Film to Treat ALS

WARREN, N.J., January 31, 2018 – Aquestive Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Riluzole Oral Soluble Film (riluzole OSF) for the treatment of amyotrophic lateral sclerosis (ALS), a debilitating disease affecting as many as 30,000 Americans.[i] Riluzole OSF is currently in late-stage clinical development.

“We hope to bring riluzole OSF to ALS patients in the second half of 2019,” said Keith J. Kendall, Chief Executive Officer of Aquestive. “Patients suffering from this debilitating neurodegenerative disease often find swallowing to be difficult or impossible. To help manage one element of this challenging disease for people with ALS and their caregivers, we developed riluzole OSF to dissolve instantly in the mouth without water, using our proprietary PharmFilm® technology.”

 

The FDA’s Office of Orphan Products Development grants drug sponsors with orphan drug designation for medications that are intended for use in diseases which affect fewer than 200,000 persons in the U.S. This designation provides sponsors with opportunities for assistance with development of designated medicines for rare diseases, including eligibility for a seven-year period of market exclusivity in the U.S. following product approval, FDA assistance in clinical trial design and an exemption from FDA user fees.

 

About Aquestive Therapeutics

Aquestive Therapeutics is a specialty pharmaceutical company that advances and commercializes medicines to solve critical healthcare problems and meaningfully improve people’s lives. Aquestive is committed to addressing immediate CNS challenges by furthering its strong pipeline of products. As the undisputed leader in developing and delivering drugs via its proprietary technologies, the Company also collaborates with pharmaceutical partners to bring new molecules to market in differentiated and highly-marketable dosage forms. For more information, please visit aquestive.com.

 

Media inquiries:
Christopher Hippolyte
christopher.hippolyte@inventivhealth.com
212-364-0458

 

Investor inquiries:
Stephanie Carrington
stephanie.carrington@icrinc.com
646-277-1282

 

[i] Sources: CDC, “National Amyotrophic Lateral Sclerosis (ALS) Registry FAQ” https://wwwn.cdc.gov/als/alsfaq.aspx (Accessed January 2018) and
ALS Association, “Quick Facts about ALS” http://www.alsa.org/news/media/quick-facts.html (Accessed January 2018)

Please complete this form:

  • To subscribe to receive information updates about products and services from Aquestive Therapeutics, or to receive information about Aquestive-sponsored clinical trials, please check the box below. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing info@aquestive.com or by calling 1-908-561-1900.

Please complete the form below and click SEND to receive a copy of “Overcoming Solubility and Permeability Challenges,” a case study detailing the achievements made by Aquestive’s formulation team to create the diazepam buccal film.

  • To subscribe to receive marketing updates about diazepam buccal film and other products and services from Aquestive, please complete the form below. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing busdev@aquestive.com.

Please complete the form to receive a demonstration kit for our PharmFilm® technology.

  • To subscribe to receive marketing updates about our PharmFilm® technology and other products and services from Aquestive, please complete the form below. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing busdev@aquestive.com.

Please complete this form:

  • To subscribe to receive marketing updates about products and services from Aquestive Therapeutics, or to receive information about Aquestive-sponsored clinical trials, please check the box below. Please also review our privacy policy, which describes how we use and process your data. If for any reason you no longer wish to receive information on Aquestive-sponsored clinical trials, you can contact us at any time by emailing clinicaltrials@aquestive.com.

Whether we are partnering to out license our PharmFilm® technology or in-licensing adjacent assets, Aquestive works hand-in-hand with our partners to address their toughest clinical and business challenges. To learn more, please complete the following form:

  • To subscribe to receive information updates about products and services from Aquestive Therapeutics, or to receive information about Aquestive-sponsored clinical trials, please check the box below. Please also review our privacy policy, which describes how we use and process your data. You may also contact us at any time by emailing busdev@aquestive.com.

Please complete the form below and click submit to receive a copy of “The Art of LGS Book.”