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ADHD & Patient Experience

Attention Deficit/Hyperactivity Disorder (ADHD) is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood.

ADHD & Patient Experience

Attention Deficit/Hyperactivity Disorder (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.

Although there is no single medical, physical, or genetic test for ADHD, qualified mental health care professionals and physicians can provide a diagnostic evaluation after gathering information from multiple sources including ADHD symptom checklists, standardized behavior rating scales, detailed histories of past and current functioning, and information obtained from family members or significant others who know the person well. Some practitioners will also conduct tests of cognitive ability and academic achievement in order to rule out a possible learning disability.

Treatment for ADHD has two important components — medications and psychotherapy interventions (for both the child and the parents; or the adult with ADHD).

In the United States, approximately 6.4 million or 11% of children and adolescents aged 4-17 have been diagnosed with ADHD. Among this group, 80% receive treatment and an 65% demonstrate clinical ADHD symptoms that persist into adulthood.

Adult ADHD prevalence is estimated at 4.4% of the population (11 million patients), double the size of the child and adolescent segment, however, only 20% receive treatment. The adult market is growing at 10% annually as a growing number of patients seek treatment. ADHD medication sales have grown 8% each year since 2010 and the US stimulant market is $18 billion as of 3Q 2022.

We believe our most advanced drug product candidate, CTx-1301, will be the first true once-daily dexmethylphenidate tablet for the treatment of ADHD, providing onset-of-action within 30 minutes and efficacy for the entire active day. CTx-1301 is a trimodal extended-release tablet, based on tablet-in-tablet technology, which provides three releases of dexmethylphenidate hydrochloride at precise times, ratio, and modality of release. Our CTx-1301 release profile is as follows:

  • Release #1: An initial immediate-release, or IR, dose providing 35% of the total daily dose beginning within five to six minutes after administration and designed to achieve therapeutic efficacy within 30 minutes; and
  • Release #2: Three hours after the administration of the dosage form, the first delayed, sustained release (DR1) provides 45% of the total daily dose released over 90 minutes; and
  • Release #3: Seven hours after the administration of the dosage form, a second delayed, immediate release (DR2, the built-in- booster) provides 20% of the total daily dose released over approximately 30 minutes.

In addition, we also believe our second drug product candidate, CTx-1302, will be the first true once-daily dextroamphetamine tablet for the treatment of ADHD, providing onset-of-action within 30 minutes and efficacy for the entire active day. CTx-1302 is a trimodal extended-release tablet, based on tablet-in-tablet technology, that provides three releases of dextroamphetamine at precise times, ratio, and modality of release.

These next-generation ADHD products have the potential to offer patients a true, once-daily, multi-release tablet. Stimulants are the most commonly prescribed class of medications for ADHD and account for approximately 90% of all ADHD medication prescriptions in the United States.

Anxiety Disorders and Patient Experience

Anxiety disorders are the most common mental health concern in the U.S. (www.nami.org). Anxiety is the feeling of fear that occurs when faced with threatening or stressful situations or can be endogenous and not have an identified stressor. It can be a normal response when confronted with danger, but, if severe and chronic and affects functioning, it could be regarded as an anxiety disorder. An estimated 31 percent of U.S. adults experience an anxiety disorder at some time in their lives.2 People may live with anxiety for years before they are diagnosed or treated. The global COVID-19 crisis has exacerbated the diagnosis and treatment of anxiety and anxiety related disorders and as a result is a priority within the class of unmet medical needs in mental health.

The characteristics and once daily patient focused release profile of CTx-2103 in under investigation. Cingulate has embarked on a program to develop CTx-2103 (buspirone), which would expand the PTR platform into the anxiety therapeutic category and extend the potential of PTR technology in another indication where multiple daily doses are required and the timing, style, and ratio of this medication delivery is paramount. A human formulation study for CTx-2103 has been completed, the results from the study are being used to inform the future clinical and regulatory strategies.