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The approval is supported by several studies which demonstrated the drug’s bioequivalence to Rilutek, the liquid riluzole formulation marketed by Sanofi.
Daniel Barber, MBA
The FDA has approved riluzole oral film (Exservan; Aquestive Therapeutics) for the treatment of amyotrophic lateral sclerosis. The approval is supported by several studies which demonstrated the drug’s bioequivalence to Rilutek, the liquid riluzole formulation marketed by Sanofi.1
"Oral films offer great promise to patients who face difficulty swallowing or administering traditional forms of medication,” said Daniel Barber, MBA, chief strategy and development officer of Aquestive, in a previous statement.2 “We believe these innovations are important and can help patients interact consistently and compliantly with their medication.”
Several riluzole formulations have come before the FDA in the last 2 years, with 7 approvals of the therapy worldwide. Most recently, in September 2018, ITF Pharma’s oral suspension, marketed as Tiglutik, was approved by the agency after being granted both fast track and orphan drug designations. That approval was the first easy-to-swallow thickened riluzole liquid for ALS. Tiglutik is administered twice daily through an oral syringe.3
"Patients suffering from this debilitating neurodegenerative disease often find swallowing to be difficult or impossible,” Keith J. Kendall, chief executive officer of Aquestive, said in a statement. “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."
Historical trials on Sanofi’s original formulation of the drug demonstrated increased survival in patients with ALS, with a difference in median survival of approximately 60 days between patients who successfully completed or failed treatment.4
The drug will be available as a 50 mg oral film meant to dissolve on the tongue taken twice daily at least 1 hour before or 2 hours after a meal. Treatment with riluzole may be associated with hepatic injury; it is contraindicated in patients who have baseline serum aminotransferases greater than 5 times the upper limit of normal. Patients should also be monitored for neutropenia and report any signs of febrile illness. Riluzole oral film should be discontinued in patients who develop interstitial lung disease.
The most common adverse reactions recorded in clinical trials were oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain. Co-administration of CYP1A2 inhibitors may increase riluzole-associated adverse reactions, and CYP1A2 inducers may result in decreased efficacy.
1. Highlights of prescribing information: Exservan. US Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212640s000lbl.pdf
2.Aquestive Therapeutics Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application for Riluzole Oral Film for Treatment of ALS [press release]. Warren, NJ: Aquestive Therapeutics; Published April 16, 2019. prnewswire.com/news-releases/aquestive-therapeutics-announces-us-food-and-drug-administration-fda-acceptance-of-new-drug-application-for-riluzole-oral-film-for-treatment-of-als-300832795.html. Accessed April 16, 2019.
3. ITF Pharma Announces FDA Approval Of TIGLUTIK™ (Riluzole) Oral Suspension for The Treatment Of Amyotrophic Lateral Sclerosis (ALS) [press release]. Berwyn, PA: ITF Pharma; Published September 6, 2018. prnewswire.com/news-releases/itf-pharma-announces-fda-approval-of-tiglutik-riluzole-oral-suspension-for-the-treatment-of-amyotrophic-lateral-sclerosis-als-300707653.html. Accessed April 16, 2019.
4. Riluzole FDA Label. FDA website. Revised 2008. accessdata.fda.gov/drugsatfda_docs/label/2009/020599s011s012lbl.pdf. Accessed April 16, 2019.