Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-400 (Hydrocortisone Oral Solution)
Eton Pharmaceuticals (Nasdaq: ETON) announced FDA acceptance of its New Drug Application (NDA) for ET-400, a proprietary patented formulation of hydrocortisone oral solution. The FDA assigned a PDUFA target action date of February 28, 2025. ET-400 is a room temperature stable formulation with patent protection through 2043.
CEO Sean Brynjelsen stated that ET-400's approval could allow Eton to capture a larger share of the oral hydrocortisone market. Combined with ALKINDI SPRINKLE®, the company anticipates peak sales exceeding $50 million annually. Eton is preparing for a potential launch in early 2025, pending FDA approval.
- FDA acceptance of New Drug Application for ET-400
- PDUFA target action date set for February 28, 2025
- Patent protection for ET-400 through 2043
- Potential for combined peak sales with ALKINDI SPRINKLE® exceeding $50 million annually
- Room temperature stable formulation of oral hydrocortisone solution
- None.
Insights
The FDA acceptance of a New Drug Application (NDA) for ET-400 is an important milestone for Eton Pharmaceuticals. Hydrocortisone is a critical medication used for treating various conditions, including adrenal insufficiency in children. This new oral solution provides a room temperature stable formulation, which could greatly benefit patients by enhancing ease of administration and storage. The stability factor is particularly important because it ensures the medication remains effective over time without the need for refrigeration, a common issue with liquid medications.
From a medical research perspective, this development could see a significant impact on patient compliance and outcomes. Convenient formulations lead to better adherence to treatment protocols, which is important in managing chronic conditions. Furthermore, the fact that Eton has a patent protection through 2043 indicates a strong competitive advantage, as it prevents other companies from developing generic versions of ET-400 during this period.
From a financial standpoint, the FDA's acceptance of the NDA for ET-400 positions Eton Pharmaceuticals favorably. The target action date set for February 28, 2025, provides a clear timeline for potential approval and subsequent market entry. The forecasted combined peak sales of
It's also worth noting the company's patent protection through 2043. This long-term protection not only secures market exclusivity but also assures investors of a sustained revenue stream without immediate threats from generic competition. Investors should monitor the developments closely as the market conditions and regulatory environment evolve.
The acceptance of the NDA marks a strategic move for Eton Pharmaceuticals to strengthen its position in the oral hydrocortisone market. The mention of capturing a greater market share indicates that ET-400 could fulfill an unmet need within the current treatment landscape. The proprietary formulation, which is stable at room temperature, meets an important market demand, potentially setting ET-400 apart from existing products that may require refrigeration.
In addition, Eton's strategy to combine the sales potentials of ET-400 and ALKINDI SPRINKLE® shows a comprehensive approach to market penetration. By addressing different facets of the market, Eton could significantly enhance its competitive edge. Market dynamics, including consumer preferences for stable, easy-to-administer medications, will likely play a important role in ET-400's adoption post-approval.
- Prescription Drug User Fee Act (PDUFA) target action date is February 28, 2025 -
- Product has patent protection through 2043 -
DEER PARK, Ill., July 15, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the Company’s New Drug Application (NDA) for ET-400, a proprietary patented formulation of hydrocortisone oral solution, has been accepted by the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2025.
“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
ET-400 is a proprietary room temperature stable formulation of oral hydrocortisone solution. The Company has been issued a patent related to the product by the U.S. Patent and Trademark Office that expires in 2043 and has additional patent applications currently under review.
About Eton Pharmaceuticals
Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has five commercial rare disease products: ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has three additional product candidates in late-stage development: ET-400, ET-600, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
Source: Eton Pharmaceuticals.
FAQ
What is the PDUFA target action date for Eton Pharmaceuticals' ET-400?
How long does Eton Pharmaceuticals (ETON) have patent protection for ET-400?
What are the projected peak sales for ET-400 and ALKINDI SPRINKLE® combined?
When does Eton Pharmaceuticals (ETON) plan to potentially launch ET-400?
