FDA Approves Riluzole Oral Suspension for Treatment of ALS
The approval of riluzole oral suspension fills a therapeutic need for patients with amyotrophic lateral sclerosis who develop swallowing impairment.
Officials with the FDA have approved riluzole (Tigultik, ITF Pharma) oral suspension for the treatment of amyotrophic lateral sclerosis (ALS), ITF Pharma announced in a press release.
Patients with ALS experience muscle weakness from the degeneration of motor neurons, typically affecting the arms and legs, speech, swallowing, and breathing. The oral suspension is the first and only easy-to-swallow thickened riluzole liquid, easing administration for the approximately 80% of patients with ALS who develop swallowing impairment, according to ITF Pharma.
“Having a therapeutic option designed to specifically overcome the challenges of disease-related dysphagia in ALS is a welcome step forward for the many doctors, caregivers, and people living with ALS who have relied on riluzole as the gold standard of treatment for more than 20 years to slow the progression of this devastating disease,” 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, said in the press release.
The approval is based on bioavailability studies comparing oral riluzole tablets with the oral suspension treatment. Riluzole has been repeatedly shown to modulate glutamate neurotransmission by inhibiting both glutamate release and postsynaptic glutamate receptor signaling.
The most common adverse effects associated with use of riluzole oral suspension are consistent with the clinical profile of oral riluzole, including oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain.
“The availability of Tigultik 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,” Dr Mitsumoto said.
Rilzuole oral suspension is administered twice daily via an oral syringe, according to the press release.
Riluzole oral suspension was approved under FDA fast track designation and ITF Pharma expects to make the oral suspension commercially available in the United States in mid-October.
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ITF Pharma Announces FDA Approval of Tiglutik (Riluzole) Oral Suspension for the Treatment of Amyotrophic Lateral Sclerosis (ALS) [news release]. ITF Pharma’s website. https://itfpharma.com/wp-content/uploads/2018/09/FINAL-FOR-FDA-FILING_US-FDA-Approves-TIGLUTIK-Press-Release_TIGLPA092018.pdf. Accessed September 6, 2018.