Eton Pharmaceuticals Submits New Drug Application to the FDA for Orphan Drug Dehydrated Alcohol Injection (DS-100)

-Granted Orphan Drug Designation by the FDA for the Treatment of Methanol Poisoning

-Since the Start of COVID-19, the FDA has Recalled More Than 75 Contaminated Hand Sanitizers Due to Risk of Methanol Poisoning

-DS-100 is Eton’s Fifth Drug Application Under FDA Review and Second Orphan Application

DEER PARK, Ill., July 27, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced it has submitted a new drug application (NDA) for dehydrated alcohol injection, previously known as the company’s DS-100 product candidate, to the U.S. Food & Drug Administration (FDA) for the treatment of methanol poisoning.

“We are very excited to add another orphan drug NDA submission to our late-stage pipeline. Our team and our partners have worked tirelessly to complete DS-100’s extensive clinical and development activities, which has allowed us to submit this application ahead of schedule,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “If approved by the FDA, we look forward to launching the product in the near future.”

Eton’s product has been granted orphan drug designation for the treatment of methanol poisoning, and as a result, the product is expected to receive seven years of market exclusivity upon its approval. The incidence of methanol poisoning has increased significantly in 2020 due to COVID-19, as unprecedented demand for hand sanitizers has led some manufacturers to improperly use methanol in their products. Earlier this month, the FDA recommended manufacturers recall more than 75 different hand sanitizers that were found to contain methanol despite being labeled as ethanol. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested. The FDA has reported cases of adults and children suffering from adverse events including blindness, hospitalization and death, due to methanol poisoning caused by methanol-based sanitizers.¹

The DS-100 NDA represents Eton’s second orphan drug candidate and fifth total drug candidate under review with the FDA. Alkindi Sprinkle, the company’s other orphan drug product, is currently under FDA review as a replacement therapy for pediatric adrenal insufficiency (AI) and has been assigned a Prescription Drug User Fee Act date of September 29, 2020. Eton’s EM-100 (preservative-free ketotifen ophthalmic solution) product candidate has an August 10, 2020 target action date.