FDA approves Tiglutik oral suspension for amyotrophic lateral sclerosis.- ITF Pharma.

ITF Pharma announced that the FDA has approved Tiglutik (riluzole) oral suspension for the treatment of amyotrophic lateral sclerosis (ALS). Tiglutik is the first and only easy-to-swallow thickened riluzole liquid for ALS and is administered twice daily via an oral syringe.

The approval of Tiglutik is based on bioavailability studies comparing oral riluzole tablets to Tiglutik oral suspension. The most common side effects of Tiglutik are consistent with the established clinical profile of riluzole and include oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension and abdominal pain. While riluzole's mechanism of action is not fully understood, in clinical studies it has been shown repeatedly to modulate glutamate neurotransmission by inhibiting both glutamate release and postsynaptic glutamate receptor signaling.

Tiglutik was approved under FDA fast-track designation, which expedites the review of drugs that have the potential to treat serious conditions and fill an unmet medical need. Tiglutik has received orphan drug designation from the FDA.