FDA Approves Riluzole Supplemental New Drug Application for Adult Patients with Amyotrophic Lateral Sclerosis

The supplemental new drug application approval expands the patient population who stand to benefit from riluzole to include patients with ALS for whom swallowing is difficult and requires the use of percutaneous endoscopic gastrostomy feeding tube.

The FDA has approved a supplemental new drug application (sNDA) that broadens the existing label of riluzole (Tiglutik, ITF Pharma) oral suspension to include administration via percutaneous endoscopic gastrostomy (PEG) tubes for the treatment of amyotrophic lateral sclerosis (ALS).

The sNDA approval expands the patient population who stands to benefit from riluzole to include those whose swallowing difficulty is complicated by alterations in nutritional status, necessitating the use of a PEG feeding tube.

"There are many medical and quality of life advantages for the use of a PEG feeding tube as an individual's ALS progresses, including the ability maintain more adequate hydration, administer medications and to potentially reduce the risk of choking and aspirating when oral ingestion becomes too challenging," Benjamin Rix Brooks, MD, medical director at the Carolinas Neuromuscular/ALS—MDA Center, said in a press release. "This expanded use for Tiglutik provides an alternate administration route for the majority of people with ALS who choose to undergo this procedure."

Difficulty swallowing, medically referred to as dysphagia, afflicts 85% of people with ALS during the course of their disease. Due to these challenges, many patients require the placement of a PEG tube, which allows nutrition, fluids, and medications to be put directly into the stomach, bypassing the mouth and esophagus, according to the press release.

The approval of riluzole oral suspension for feeding tube administration is important for adult patients with ALS when swallowing becomes too difficult. Tiglutik was initially approved in 2018 as the first and only easy-to-swallow oral suspension of riluzole for the treatment of ALS and administered twice daily via an oral syringe.

This FDA approval of riluzole is based on a study that showed it was bioequivalent when administered intragastrically, or through the stomach, and orally. The most common adverse events were oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain.

Having an oral suspension formulation precludes the need for manipulation of tablets by patients and caregivers, eases administration, and may provide an opportunity for more accurate dosing and enhanced patient compliance, according to the press release.

Reference

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 [press release]. Berwyn, PA. Biospace website. Published December 13, 2019. https://www.biospace.com/article/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-feeding-tube/. Accessed December 16, 2019.