Cingulate Gains FDA Waiver, Moves Closer to ADHD Treatment Approval
Cingulate Inc. Receives FDA Fee Waiver
Cingulate Inc., a prominent biopharmaceutical organization, has recently announced a pivotal milestone in its journey towards FDA approval for its lead ADHD asset, CTx-1301. The company has received a significant fee waiver of approximately $4.3 million under the PDUFA provision for the fiscal year.
What This Waiver Means for Cingulate
The fee waiver allows Cingulate to conserve considerable financial resources, a welcome boost as the company gears up for its New Drug Application (NDA) submission. This waiver is an important factor that supports the company’s commitment to bringing innovative ADHD treatments to the market.
Implications of the Waiver on Cingulate's Operations
The waiver comes from the small business provision under the Federal Food, Drug, and Cosmetic Act, allowing Cingulate to redirect these funds towards crucial development stages and operational activities. Shane J. Schaffer, Chairman and CEO of Cingulate, expressed optimism about this development, highlighting that it strengthens the company’s financial foundation for the marketing of CTx-1301.
Cingulate’s Approach to ADHD Treatment
CTx-1301 is designed utilizing Cingulate's proprietary Precision Timed Release™ (PTR™) technology, which focuses on providing a more controlled and effective medication delivery method. This approach aims to improve therapeutic outcomes for patients suffering from ADHD.
The Need for Innovative ADHD Treatments
Attention Deficit Hyperactivity Disorder (ADHD) affects millions of individuals, starting in childhood and often continuing into adulthood. Statistics show that over 20 million people in the U.S. are living with this condition. A recent finding indicates that a majority of adolescents and children diagnosed with ADHD are not receiving adequate treatment. This underscores the necessity for innovative solutions in the ADHD treatment landscape.
Understanding CTx-1301
The lead candidate, CTx-1301, represents a significant advancement in ADHD treatment methodologies. It harnesses a unique multi-core formulation that ensures optimal absorption and efficacy throughout the day. The aim is to improve adherence to treatment by minimizing the frequency and complexity of dosing.
The Functionality of the Precision Timed Release™ Platform
Cingulate's innovative drug delivery system ensures that the active pharmaceutical ingredient, dexmethylphenidate, is released in a controlled manner. By implementing a tablet-in-tablet design, Cingulate aims to provide a consistent therapeutic effect which is crucial for effective ADHD management.
Looking Ahead: Cingulate’s Future Plans
Cingulate is not only focused on ADHD treatment; it is also exploring other conditions that may benefit from the PTR technology. The ability to potentially adapt this platform for various therapeutic applications could expand Cingulate's pipeline significantly, enhancing its market presence and impact.
About Cingulate Inc.
Cingulate Inc. is dedicated to improving treatment regimens and outcomes for patients suffering from common yet challenging conditions, including ADHD. It's headquartered in Kansas City and its commitment to innovative solutions sets it apart in the biopharmaceutical landscape.
Contact Information
For further information or inquiries, individuals can contact Thomas Dalton, Vice President of Corporate Communications, via email at tdalton@cingulate.com or by phone at (913) 942-2301.
Frequently Asked Questions
What is Cingulate Inc.'s lead product?
Cingulate Inc.'s lead product is CTx-1301, designed for treating ADHD.
How much is the FDA fee waiver that Cingulate received?
The FDA has granted Cingulate a fee waiver of approximately $4.3 million.
What technology does Cingulate use for its treatments?
Cingulate uses its proprietary Precision Timed Release™ (PTR™) technology.
Why is the fee waiver important for Cingulate?
The fee waiver allows Cingulate to save funds that can be redirected to further product development.
Which conditions is Cingulate exploring for future treatments?
Cingulate is exploring treatments for ADHD and anxiety disorders through its innovative technologies.
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