Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Topiramate Oral Solution

Rhea-AI Summary

Eton Pharmaceuticals has received FDA acceptance for its new drug application (NDA) for topiramate oral solution, targeting pediatric and adolescent patients. The application, which includes three indications for seizures and migraine prevention, has a PDUFA date of August 6, 2021. This marks a significant step for Eton, which has three neurology-focused oral liquid products submitted to the FDA, all slated for approval in 2021. The company currently has three FDA-approved products and aims to develop treatments for rare pediatric diseases.

Positive

• FDA acceptance of NDA for topiramate oral solution enhances product pipeline.
• PDUFA date set for August 6, 2021, indicating a clear regulatory timeline.
• Targets critical indications, potentially expanding patient access and market share.

Negative

• None.

Application Assigned a PDUFA Date of August 6, 2021

DEER PARK, Ill., Dec. 17, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s new drug application (NDA) for topiramate oral solution. The application has been assigned a Prescription Drug User Fee Act (PDUFA) date of August 6, 2021.

The application was submitted for three indications, including: monotherapy for treatment of partial-onset or primary general tonic-clonic seizures in patients two years age and older; adjunctive therapy for treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients two years of age and older; and as preventative treatment of migraine in patients 12 years of age and older. Topiramate is one of Eton’s three neurology-focused oral liquid product candidates that have been submitted to the FDA, and all three product candidates are expected to be approved and launched in 2021.

About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases. The company currently owns or receives royalties from three FDA-approved products, including ALKINDI^® SPRINKLE, Biorphen^®, and Alaway Preservative Free^®, and has six additional products that have been submitted to the FDA.

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.

Company Contact:
David Krempa
dkrempa@etonpharma.com
612-387-3740

FAQ

What is the significance of Eton Pharmaceuticals' NDA for topiramate oral solution?

The NDA acceptance by the FDA is crucial as it lays the groundwork for potential market approval and expands Eton's treatment portfolio.

When is the PDUFA date for Eton Pharmaceuticals' topiramate application?

The PDUFA date for the topiramate oral solution application is set for August 6, 2021.

What conditions does the topiramate oral solution target?

Topiramate oral solution targets partial-onset seizures, primary general tonic-clonic seizures, and migraine prevention in specified age groups.

How many FDA-approved products does Eton Pharmaceuticals currently have?

Eton Pharmaceuticals owns or receives royalties from three FDA-approved products.

What are the future prospects for Eton Pharmaceuticals' product candidates?

Eton expects to launch three neurology-focused oral liquid products in 2021, pending FDA approvals.