FDA Clears Cingulate to File for Marketing Approval of CTx-1301 in the Treatment of ADHD
Cingulate has received FDA confirmation on the requirements for filing a New Drug Application (NDA) for its Phase 3 candidate, CTx-1301, aimed at treating ADHD in patients aged six and older. The FDA has agreed that data from ongoing Phase 3 studies are sufficient for submission under the 505(b)(2) pathway, eliminating the need for further fixed dose and onset/duration studies. Cingulate will also conduct a brief Phase 1 fed/fast study to include in the NDA. The company aims to submit the NDA in the first half of 2025. Cingulate is also negotiating with potential commercialization partners and payers to maximize market access for CTx-1301, which may benefit over 60% of ADHD patients currently using booster doses. The drug has shown promising results, with patients expressing a desire to continue its use post-trial.
- FDA clearance to file NDA for CTx-1301.
- Phase 3 data considered sufficient by FDA.
- CTx-1301 potentially benefits >60% of ADHD patients using booster doses.
- Advancing discussions with commercialization partners.
- Engaging with payers for reimbursement and market access.
- Clear pathway for NDA submission by first half of 2025.
- Promising Phase 3 results presented at APSARD and Psych Congress.
- NDA submission delayed until first half of 2025.
- Additional Phase 1 fed/fast study required.
Insights
Analyzing the FDA clearance for Cingulate's CTx-1301, it's important to understand the potential impact on the ADHD treatment landscape. The news signifies that the data collected so far in Phase 3 trials is sufficient for a New Drug Application (NDA) submission. This is a significant step, considering that CTx-1301 could potentially benefit over
The Phase 1 fed/fast study that Cingulate plans to conduct is a relatively standard requirement to understand how food intake affects drug absorption. Given it's a short study (two to three weeks), its results will likely be positive in time for the NDA submission in the first half of 2025.
The fact that current treatment options often require booster doses suggests a significant unmet need in the market. If CTx-1301 can provide a longer duration of efficacy with a single dose, it may see strong uptake from both prescribers and patients.
For an investor, the primary consideration is whether the drug’s efficacy and safety profile will meet FDA approval. Given the FDA's alignment with the current data and the ongoing preparation for NDA, the prospects seem optimistic. However, this also hinges on successful commercialization strategies and payer engagement.
From a financial perspective, Cingulate Inc.'s announcement could significantly influence its stock performance. The positive FDA feedback is a strong indicator that CTx-1301 may soon enter the market. This could substantially enhance revenue streams, particularly as the drug addresses a large segment of the ADHD market currently using booster doses.
Investors should consider the timing of the NDA filing (first half of 2025) and the potential market entry shortly thereafter. This timeline suggests that revenue impact will be more pronounced in the medium to long term rather than immediate.
Another critical factor is the company's engagement with commercialization partners and payers. Effective partnerships will be important for widespread adoption and market penetration. Early discussions with payers will be essential to ensure coverage and reimbursement, which are key to driving sales volumes.
Overall, while the news is promising, investors should keep an eye on further developments, particularly the outcomes of the Phase 1 study and any partnership announcements.
The ADHD medication market is competitive, with several established players. However, CTx-1301’s potential to reduce the need for immediate-release booster doses could be a differentiator. The market is substantial and a product offering improved patient compliance and efficacy could capture significant share.
Effect size is a critical term here. While statistical significance often depends on sample size, effect size measures the magnitude of the treatment's impact, giving a clearer picture of clinical relevance. For CTx-1301, the reported effect size appears promising, which could translate to better therapeutic outcomes and thus higher market adoption.
If the drug gains approval, its market success will depend on several factors: effective marketing strategies, payer acceptance and competitive pricing. Given the large target population and the reported demand among trial participants, CTx-1301 has strong market potential if it meets regulatory and payer requirements.
Phase 3 Data Collected to Date Sufficient for Submission of New Drug Application
CTx-1301 Could Benefit >
Advancing Discussions with Commercialization Partners
Ready to Engage with Payers for Reimbursement and Market Access
KANSAS CITY, Kan., May 21, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced that it has received confirmation from and is aligned with the U.S. Food and Drug Administration (FDA) on the requirements necessary for filing a New Drug Application (NDA) for its lead Phase 3 candidate CTx-1301 (dexmethylphenidate), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years of age or older.
Details from the FDA communication to Cingulate include the following:
- Per the 505(b)(2) pathway, submission of CTx-1301’s NDA does not require continuation of the fixed dose study and the onset and duration study;
- Data collected to date from these two Phase 3 studies will be included in the filing; and
- Contemporaneously with the preparation of the NDA filing, Cingulate will conduct a Phase 1 fed/fast study, the study is expected to last approximately two to three weeks, with the results being included in the NDA filing.
“We are pleased with the FDA’s guidance and perspective regarding our pathway to a timely NDA filing, and we will proceed to complete all remaining requirements accordingly,” said Cingulate Chairman and CEO Shane J. Schaffer. “We also believe this communication provides additional go-to-market momentum as we continue to meet with potential partners for the outlicensing of CTx-1301 in the United States and abroad. Now that we have a clear path to submission, we look forward to engaging with key payer stakeholders to achieve maximum access and market penetration to benefit ADHD patients and their families.”
Cingulate has begun NDA preparation and expects to submit its filing in the first half of 2025.
Ann Childress, M.D., President, Center for Psychiatry and Behavior Medicine, Inc., and lead investigator of Cingulate’s CTx-1301 onset and duration study, stated, “The treatment effect size of CTx-1301 was remarkable given the current effect sizes observed in the marketplace. Many patients require longer duration of efficacy and must add a second, or booster, dose to ensure treatment effect over their entire active day. The patients I observed, once notified they were taking CTx-1301, have expressed a desire to remain on the medication after the trial concluded.”
“If approved,” Childress continued, “I believe CTx-1301 could potentially benefit the more than 60 percent of patients currently using immediate-release booster doses to extend the efficacy of their medications.”
Earlier this year, Cingulate presented results from the Phase 3 adult efficacy and safety study of CTx-1301 at the 2024 American Professional Society of ADHD and Related Disorders (APSARD) conference in Orlando, FL.
The results were previously presented at the 2023 Psych Congress, where a poster describing the data was selected as a finalist for the Psych Congress’s First Annual Poster Awards.
The Cingulate poster presented at APSARD provided additional insight regarding CTx-1301’s ADHD leading effect size. Effect size conveys clinical significance rather than statistical significance, is not reliant on sample size, and allows for comparison across trials. The poster presented may be viewed here.
About Attention Deficit/Hyperactivity Disorder (ADHD)
ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., approximately 6.4 million children and adolescents (11 percent) aged under the age of 18 have been diagnosed with ADHD. Among this group, approximately 80 percent receive treatment, with 65-90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Adult ADHD prevalence is estimated at approximately 11 million patients (4.4 percent), almost double the size of the child and adolescent segment combined. However, only an estimated 20 percent receive treatment.
About CTx-1301
Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. While stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be providing patients with an entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off.
About Precision Timed Release™ (PTR™) Platform Technology
Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here.
About Cingulate®
Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of attention deficit/hyperactivity disorder (ADHD), Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders.
Cingulate is headquartered in Kansas City. For more information visit Cingulate.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on April 1, 2024. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.
Investor Relations
Thomas Dalton
Vice President, Investor & Public Relations, Cingulate
TDalton@cingulate.com
913-942-2301
Matt Kreps
Darrow Associates
mkreps@darrowir.com
214-597-8200
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/00c8b334-57ec-49cf-9a59-02d75463089e
FAQ
What is CTx-1301?
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How many ADHD patients could benefit from CTx-1301?
What pathway is Cingulate using for the NDA submission of CTx-1301?
What additional study is required for the NDA submission of CTx-1301?
