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Eton Pharmaceuticals' ET-400 (Hydrocortisone Oral Solution) Receives FDA Acceptance

• Eton Pharmaceuticals' New Drug Application (NDA) for ET-400, an oral hydrocortisone solution, has been accepted by the FDA. • The FDA has assigned a PDUFA target action date of February 28, 2025, for ET-400, a treatment for adrenocortical insufficiency. • ET-400 is a room-temperature stable, patented formulation, potentially capturing a significant portion of the oral hydrocortisone market. • Eton anticipates combined peak sales of over $50 million annually for ET-400 and ALKINDI SPRINKLE® upon approval.

Eton Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for ET-400, a proprietary, patented oral solution of hydrocortisone. This acceptance marks a significant step toward providing an accessible liquid formulation of hydrocortisone, particularly beneficial for pediatric patients. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2025.

Addressing Adrenocortical Insufficiency

ET-400 is designed to treat adrenocortical insufficiency, a condition where the adrenal glands do not produce enough cortisol. Hydrocortisone is a synthetic form of cortisol used to replace the deficient hormone. A stable, easy-to-administer liquid formulation addresses a critical need, especially for children who may have difficulty swallowing tablets or capsules.

Market Potential and Company Strategy

Sean Brynjelsen, CEO of Eton Pharmaceuticals, stated, "The acceptance of our NDA is a significant milestone toward our efforts of bringing this important and highly in-demand liquid formulation to children. Once approved, we believe ET-400 will allow us to capture a greater percentage of the oral hydrocortisone market and, together with ALKINDI SPRINKLE®, achieve combined peak sales of more than $50 million annually. We look forward to working with the FDA and preparing for a potential launch in early 2025."

Formulation and Intellectual Property

ET-400 features a room-temperature stable formulation, enhancing its convenience and usability. Eton Pharmaceuticals has been granted a patent by the U.S. Patent and Trademark Office for this formulation, which is set to expire in 2043. Additional patent applications are currently under review, further solidifying the company's intellectual property position.

Eton Pharmaceuticals' Pipeline

Eton Pharmaceuticals focuses on developing and commercializing treatments for rare diseases. The company's current commercial portfolio includes ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. In addition to ET-400, Eton has other late-stage product candidates, including ET-600 and ZENEO® hydrocortisone autoinjector, indicating a robust pipeline aimed at addressing unmet needs in rare disease treatment.
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Reference News

[1]
Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-400 (Hydrocortisone Oral Solution)
drugs.com · Jul 15, 2024

Eton Pharmaceuticals' NDA for ET-400, a hydrocortisone oral solution, was accepted by the FDA with a PDUFA target action...

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