FDA Approves Broader Label for ALS Drug, Riluzole

Different route of administration added

ITF Pharma has been approved to broaden the existing label for Tiglutik (riluzole) oral suspension to include administration via percutaneous endoscopic gastrostomy tubes for the treatment of amyotrophic lateral sclerosis, sometimes called Lou Gehrig's disease.

Riluzole is the gold standard of treatment to slow the progression of ALS. 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.

The FDA approval is based on a study that showed Tiglutik was bioequivalent when administered intragastrically and orally.

In clinical studies, the most common side effects were oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension and abdominal pain.

Source: ITF Pharma, December 13, 2019