~ TIGLUTIK is the only formulation of riluzole indicated for both oral and PEG tube administration ~

Berwyn, Pa., Dec. 13, 2019 – EDW Pharma, a U.S.-based specialty pharmaceutical company and subsidiary of Italfarmaco, a privately-held European specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (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 (ALS). This supplemental new drug application (sNDA) 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.

Approximately 20,000 Americans are living with ALS.i Difficulty swallowing, medically referred to as dysphagia, afflicts 85 percent of people with ALS during the course of their disease.ii Due to these challenges, many patients require the placement of a PEG tube, which allows nutrition, fluids and medications to be put directly into the stomach, bypassing the mouth and esophagus.

“There are many medical and quality of life advantages for the use of a PEG feeding tube as an individual’s ALS progresses, including the ability maintain more adequate hydration, administer medications and to potentially reduce the risk of choking and aspirating when oral ingestion becomes too challenging,” said Benjamin Rix Brooks, M.D., medical director at the Carolinas Neuromuscular/ALS – MDA Center. “This expanded use for TIGLUTIK provides an alternate administration route for the majority of people with ALS who choose to undergo this procedure.”

The American Academy of Neurology (AAN) recommends an evaluation of the nutritional status of ALS patients every three months and advises consideration of feeding tube placement when patients demonstrate swallowing difficulty or alterations in nutritional status.iii

“We are very pleased the FDA has approved the application to broaden the existing label for TIGLUTIK to include PEG tube administration. This news marks another important step forward in the treatment of ALS and addresses an unmet treatment need of the ALS community,” said Peter Cook, president and chief executive officer of EDW Pharma.
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 gold standard of 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.