FDA Approves ALS Drug Riluzole Oral Suspension for Use in Feeding Tubes

Peter Cook

ITF Pharma has announced that the FDA has approved a supplemental new drug application to broaden the indication for riluzole (Tiglutik) oral suspension to include administration via percutaneous endoscopic gastrostomy (PEG) tubes in patients with amyotrophic lateral sclerosis (ALS).¹

“We are very pleased the FDA has approved the application to broaden the existing label for TIGLUTIK to include PEG tube administration. This news marks another important step forward in the treatment of ALS and addresses an unmet treatment need of the ALS community,” said Peter Cook, president and chief executive officer of ITF Pharma, in a statement.¹

Approximately 85% of people with ALS experience dysphagia as the disease progresses. The American Academy of Neurology recommends that nutritional status in patients with ALS be evaluated every 3 months and recommends that PEG tube placement be considered if a patient demonstrates difficulty swallowing or shows alterations in their nutritional status.

Riluzole oral suspension was originally approved in the US in 2018, where it was granted fast track and orphan drug designations by the FDA.² That approval was based on findings from bioavailability studies which compared the tablet formulation of riluzole to the oral suspension formulation, which is administered twice daily via oral syringe.² Study data showed that the total exposure of riluzole 50 mg tablets and the riluzole 5 mg/mL oral suspension was essentially equivalent (ratio, 106.84%; 90% CI, 96.98-117.71). The oral suspension resulted in a more rapid absorption (Tmax, ~30 mins) with a maximum concentration that was roughly 20% higher than the tablets (ratio, 122.32%; 90% CI, 103.28-144.88).

More recently, the FDA approved Aquestive’s riluzole oral film, marketed as Exservan.³ That approval was based on study results that demonstrated the drug’s bioequivalence to Rilutek, the liquid formulation of riluzole that is marketed by Sanofi. The film is intended to ease medication administration in patients with ALS who have difficulty swallowing or tolerating the administration of other formulations.

According to the prescribing information,⁴ the recommended dosage of riluzole oral suspension in patients with PEG tubes is 50 mg twice daily, every 12 hours, at least 1 hour before or 2 hours after a meal.

REFERENCES

1. ITF Pharma announces FDA approval of supplemental new drug application (sNDA) for Tiglutik (riluzole) oral suspension for the treatment of amyotrophic lateral sclerosis (ALS) with a percutaneous endoscopic gastronomy (PEG) feeding tube [news release]. Berwyn, PA: ITF Pharma. December 13, 2019. prnewswire.com/news-releases/itf-pharma-announces-fda-approval-of-supplemental-new-drug-application-snda-for-tiglutik-riluzole-oral-suspension-for-the-treatment-of-amyotrophic-lateral-sclerosis-als-with-a-percutaneous-endoscopic-gastronomy-peg-feedin-300974753.html. Accessed December 13, 2019.

2. ITF Pharma announces FDA approval of tiglutik (Riluzole) oral suspension for the treatment of amyotrophic lateral sclerosis (ALS) [press release]. Berwyn, PA: ITF Pharma. 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 September 6, 2018.

3. Highlights of prescribing information: Exservan. US Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212640s000lbl.pdf

4. Highlights of prescribing information: Tiglutik. US Food and Drug Administration. https://tiglutikblob.blob.core.windows.net/tiglutik-web-assets/TIGLUTIK_PI_with_PEG_Updated_12_2019.pdf