FDA approves expanded label for Tiglutik in amyotrophic lateral sclerosis.- ITF Pharma

ITF Pharma announced that the FDA has approved 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. This supplemental new drug application approval expands the patient population who stand to benefit from Tiglutik to include individuals whose swallowing difficulty is complicated by alterations in nutritional status, necessitating the use of a PEG feeding tube.

This FDA approval of Tiglutik is based on a study that showed Tiglutik was bioequivalent when administered intragastrically and orally.iv 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 the mechanism of action of riluzole 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.

Comment: Tiglutik, initially approved in 2018, is an oral suspension formulation of riluzole which helps fulfill an important therapeutic unmet need for the approximately 85 percent of ALS patients who develop dysphagia. Riluzole has been the standard treatment since 1995 to slow the progression of ALS, an ultimately fatal neurodegenerative disease that still has no cure. Tiglutik has received orphan drug designation from the FDA.