Therapy Areas: Central Nervous System
ITF Pharma wins FDA approval for expanding the existing label of TIGLUTIK to include administration via percutaneous endoscopic gastrostomy (PEG) tubes in ALS patients
16 December 2019 -

Pharmaceutical company ITF Pharma revealed on Friday the receipt of US Food and Drug Administration (FDA) approval for its application to broaden the existing label for TIGLUTIK (riluzole) oral suspension to include administration via percutaneous endoscopic gastrostomy (PEG) tubes for the treatment of amyotrophic lateral sclerosis (ALS).

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is a progressive, ultimately fatal neurodegenerative disease, marked by a gradual degeneration of nerve cells of the central nervous system that control voluntary muscle movement.

Following the US FDA supplemental new drug application (sNDA) approval of TIGLUTIK, the company said it expands the patient population to include individuals whose swallowing difficulty is complicated by alterations in nutritional status, necessitating the use of PEG feeding tube.

Medically referred to dysphagia, the difficulty in swallowing afflicts 85% of ALS during the course of their disease. The patients require a PEG tube, which allows nutrition, fluids and medications to be put directly into the stomach, bypassing the mouth and esophagus.

The company said TIGLUTIK is an oral suspension formulation of riluzole and is the only formulation of riluzole indicated for both oral and PEG tube administration. It is administered twice daily by either an oral syringe or using a PEG tube.

This FDA approval is based on a study that showed TIGLUTIK was bioequivalent when administered intragastrically and orally. While the mechanism of action of riluzole is not fully understood, it is shown repeatedly to modulate glutamate neurotransmission by inhibiting both glutamate release and postsynaptic glutamate receptor signaling, concluded the company.



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