Eton Pharmaceuticals Submits New Drug Application to the FDA for Orphan Drug Dehydrated Alcohol Injection (DS-100)
Eton Pharmaceuticals (Nasdaq: ETON) has submitted a new drug application (NDA) for its product DS-100, aimed at treating methanol poisoning, which has seen increased cases during the COVID-19 pandemic. The FDA has granted orphan drug designation for DS-100, promising seven years of market exclusivity upon approval. The urgency in the market arises from the recall of over 75 hand sanitizers containing methanol. This NDA marks Eton's second orphan drug submission and fifth overall under FDA review, which also includes other candidates like Alkindi® Sprinkle.
- Granted orphan drug designation for DS-100, leading to potential seven years of market exclusivity.
- Addressing significantly increased cases of methanol poisoning linked to recalled hand sanitizers.
- None.
-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.
1 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-methanol
About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, acquiring, and commercializing innovative products. Eton is primarily focused on hospital injectable and pediatric rare disease products. The company’s first commercial product, Biorphen, is the only FDA approved ready-to-use formulation of phenylephrine injection and was launched in December 2019. The company’s lead pediatric product is the orphan drug Alkindi® Sprinkle, which is currently under review with the FDA. The company has an additional seven products under development, including four that are under review with the FDA.
Forward-Looking Statements
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Company Contact:
David Krempa
dkrempa@etonpharma.com
612-387-3740
FAQ
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