The US Food and Drug Administration (FDA) approved Tiglutik (riluzole) oral suspension for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. The product was previously granted Fast Track Designation and Orphan Drug Designation by the FDA.
Tiglutik is supplied as a thickened riluzole liquid that is intended to ease administration for patients with dysphagia. “The availability of Tiglutik 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,” said Hiroshi Mitsumoto, MD, DSc, Wesley J. Howe professor of neurology at Columbia University at The Neurological Institute of New York and New York-Presbyterian Hospital/Columbia University Medical Center.
The FDA approval was supported by data from bioavailability studies comparing riluzole tablets and Tiglutik oral suspension. The mechanism by which riluzole exerts its therapeutic effects in ALS patients is unknown, however clinical studies have shown that it modulates glutamate neurotransmission by inhibiting both glutamate release and postsynaptic glutamate receptor signaling.
Oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain are the most common side effects of riluzole oral suspension; these side effects are consistent with the established clinical profile of riluzole.
By inhibiting both glutamate release and postsynaptic glutamate receptor signaling, riluzole has been shown to modulate glutamate neurotransmission repeatedly in clinical studies, despite the fact that the treatment’s mechanism of action is not fully understood.
“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,” Calaneet Balas, president and chief executive officer at The ALS Association, added.
Riluzole oral suspension was approved under FDA fast-track designation. Previously, riluzole was granted an orphan drug designation by the FDA. Tiglutik will be available as a 50mg/10mL strength oral suspension in 300mL bottles in 2-count cartons with supplies. The product is anticipated to launch in mid-October.
For more information visit Tiglutik.com.