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ITF Pharma, a U.S.-based specialty pharmaceutical company and a subsidiary of Italfarmaco, a privately-held European specialty pharmaceutical company, committed to investing in and commercializing impactful medicines in therapeutic areas with unfulfilled needs, announced today that the U.S. Food and Drug Administration (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.

"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," said 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. "The availability of Tiglutik 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."

"This approval marks an important step forward in the treatment of ALS. The ALS Association would like to thank the FDA and ITF Pharma for working together to bring this important new formulation of riluzole to the ALS community," said Calaneet Balas, president and chief executive officer at The ALS Association.

"We are very pleased with the FDA approval of Tiglutik and we look forward to making the first and only easy-to-swallow thickened riluzole liquid for ALS commercially available in the U.S. in mid-October through our highly-specialized field sales team," said Denny Willson, chief executive officer of ITF Pharma. "ITF is committed to supporting the ALS community and to helping people living with ALS find affordable access to Tiglutik. Therefore, we have partnered with a specialty pharmacy to create a simple and straightforward product support program that will help patients receive Tiglutik quickly and with ease. This reflects our underlying mission to provide valuable therapeutic options and support programs that make a positive difference in the lives of both patients and healthcare providers."

Paolo Bettica, MD, PhD, vice president, research and development of Italfarmaco, commented: "This is the seventh approval worldwide for Tiglutik and a very significant advance for ITF Pharma and Italfarmaco. We are pleased to bring this new therapeutic option to ALS patients in the United States."

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.


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