FDA Approves of Oral Suspension of Riluzole for Patients With Amyotrophic Lateral Sclerosis
The Food and Drug Administration (FDA) has approved a new formulation of riluzole (Tiglutek; ITF Pharma, Berwyn, PA) for patients with amyotrophic lateral sclerosis (ALS). This is the first oral suspension and fulfills an unmet need for the 80% of patients with dysphagia in ALS. The new formulation will be commercially available in October, 2018. The new formulation is an easy-to-swallow thickened liquid administered twice daily with an oral syringe.
Although riluzole's mechanism of action is not fully understood, it has thought to be via modulation of glutamatergic through inhibition of glutamate release and postsynaptic glutamate-receptor signaling.
Approval was based on bioavailability studies comparing oral riluzole tablets to riluzole oral suspension. The most common side effects of were consistent with the established clinical profile of riluzole.
"Having a therapeutic option designed to specifically overcome the challenges of disease-related dysphagia in ALS is a welcome step forward for the many doctors, caregivers and people living with ALS who have relied on riluzole as the gold standard of treatment for more than 20 years to slow the progression of this devastating disease," said Hiroshi Mitsumoto, MD, DSc, of Columbia University, New York, NY. "The availability of Tiglutek oral suspension precludes the need for manipulation of tablets by patients or caregivers, easing administration and may provide an opportunity for more accurate dosing and enhanced patient compliance."
"This approval marks an important step forward in the treatment of ALS. The ALS Association would like to thank the FDA and ITF Pharma for working together to bring this important new formulation of riluzole to the ALS community," said Calaneet Balas, President and Chief Executive Officer at The ALS Association