Dextroamphetamine

General Merrick Garland announcing the results of a nationwide healthcare fraud investigation at a 27 June press conference at the US Department of Justice. Credit: Samuel Corum via Shutterstock. The US Justice Department has charged 193 people in a major enforcement action, accusing them of participating in healthcare fraud schemes worth $2.75bn. The two-week crackdown involved 76 doctors, nurses, and other medical professionals. The defendants are accused of several scams, such as illegally distributing millions of Adderall (amphetamine) pills and other stimulants. This also included fraudulent activity that involved corporate executives distributing tainted and misbranded HIV medication, which amounted to $90m in losses. Ruthia He, founder and CEO of San Francisco-based digital technology company Done Global, was arrested on 13 June. He has been charged with participating in a scheme to distribute Adderall (amphetamine / dextroamphetamine) over the internet and conspired to commit healthcare fraud in connection with the submission of fraudulent claims for reimbursement for the drug and other stimulants. Adderall is a drug used to treat attention deficit hyperactivity disorder (ADHD). Also included in this crackdown were three executives of a pharmaceutical distributor who allegedly bought HIV medications through fraudulent schemes and resold them with falsified documents to pharmacies nationwide. This led to patients unknowingly receiving mislabelled drugs, one of whom fell unconscious for 24 hours after taking the wrong medication. Attorney General Garland said in a statement: “It does not matter if you are a trafficker in a drug cartel or a corporate executive or medical professional employed by a healthcare company. If you profit from the unlawful distribution of controlled substances, you will be held accountable.” See Also: CHMP recommends authorisation for Pfizer-BioNTech’s Covid-19 vaccine Verona scores FDA approval for Ohtuvayre as COPD maintenance therapy Other instances involve allegations against two owners of wound care firms who allegedly accepted over $330m in kickbacks in a scheme to fraudulently bill Medicare for amniotic wound grafts— biological dressings used to promote the healing of wounds. In Arizona, a woman is accused by prosecutors of improperly billing the state’s Medicaid agency for substance abuse treatment services that either lacked genuine benefit or were never actually administered. The agency announced that they had also seized $230m in cash, luxury vehicles, gold, and other assets in connection with these cases, adding the schemes resulted in $1.6bn in losses. “Through this action, we in federal law enforcement send a clear and strong message—that we will hold accountable those healthcare providers and prescribers who prey on their patients for profit and disregard the first rule of medical care: do no harm,” said US Secretary of Homeland Security Alejandro Mayorkas.

Phase 3 Data Collected to Date Sufficient for Submission of New Drug Application CTx-1301 Could Benefit >60% of ADHD Patients Currently Using Immediate-Release Booster Doses 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 Cingulate's Precision Timed Release Technology™ (PTR™) Platform Technology Cingulate® is developing ADHD product candidates capable of achieving true once-daily dosing using the Company’s innovative Precision Timed Release™ (PTR™) drug delivery platform technology incorporating a proprietary Erosion Barrier Layer (EBL) that provides control of drug release at precise, pre-defined times with no release of drug prior to the intended release.The technology is an erodible barrier layer that is wrapped around a drug containing core to give a tablet-in-tablet dose form. The barrier layer is designed to erode at a controlled rate until eventually the drug is released from the core tablet.CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine) have pioneering compression technology with specialized release characteristics that may enable patients to take one tablet per day and avoid the use of additional immediate release “boosters.”We believe our most advanced drug product candidate, CTx-1301, will be the first true once-daily dexmethylphenidate tablet