Why Another ADHD Stimulant? Cingulate Inc. Believes It's All About The Timing

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People diagnosed with attention-deficit/hyperactivity disorder (ADHD) have several options for treatment, but most of the medications available require them to take more than one dose a day.

Cingulate Inc. CING believes that it is on the verge of changing that.   

Founded in 2013 by Dr. Shane J. Schaffer, Dr. Raul R. Silva, and Dr. Matthew Brams, Cingulate Inc. (Cingulate) is a clinical-stage biopharmaceutical company that is using its proprietary Precision Timed Release™ (PTR™) drug-delivery technology to build and advance a pipeline of pharmaceutical products to help patients who have ADHD.

The company believes its lead asset, CTx-1301, will be the first true once-daily medication for the treatment of ADHD. Clinical studies have shown that the drug takes effect within 30 minutes and because of its trimodal release PTR technology, it is effective for what Cingulate has coined the “entire active day.”

“Stimulants currently capture $15.3 billion of the ADHD market, but none of them provide entire active-day efficacy like our next-generation therapeutics are designed to do,” says Dr. Schaffer, Cingulate’s Chairman and Chief Executive Officer. “By eliminating the need for booster doses, improving tolerability, and minimizing or eliminating the “crash” traditionally associated with ADHD medication wear off, we believe we can fulfill the long-standing unmet needs of ADHD patients young and old.” 

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.   

Cingulate Chief Medical Officer, Dr. Matthew Brams, a psychiatrist for over 30 years and a key opinion leader within the ADHD community, has been a lead investigator in nearly all pivotal trials involving medications used to treat ADHD currently. What ultimately differentiates CTx-1301 from other ADHD medications, he says, boils down to the proportion, timing, and style of the release.  

“While other products may use about 50 percent of the drug upfront, CTx-1301 delivers 35 percent of the total daily dose immediately, 45 percent of the total daily dose as a 90-minute sustained release beginning three hours later, and the final 20 percent of the total daily dose immediately seven hours after administration, all contained within one easy to take tablet. It’s about delivering the right dosage, at the right time, in the right ratio, and in the right style,” said Dr. Brams.

While Cingulate’s initial focus is on the treatment of ADHD, it is currently developing additional medications with its technology to improve outcomes to treat other conditions. It has embarked on a clinical development program with CTx-2103 (buspirone hydrochloride), which would expand the PTR platform within the anxiety therapeutic category. 

The ADHD market is dominated by four main stimulants: Takeda’s Vyvanse and Adderall XR, Johnson & Johnson’s JNJ Concerta, and Novartis Pharmaceuticals Corp.’s NVS Focalin XR, which account for nearly $12 billion or 75 percent of the spending in the stimulant category and 54 percent of all stimulant prescriptions. 

Although those medications purportedly are effective if taken once a day, it is estimated that 60% of patients still require a booster dose in the afternoon to cover the entire active day.

A Growing Market? 

With sales of ADHD medication increasing 8 percent each year since 2010, Cingulate could be in a position to capture a significant share of the $18 billion total ADHD prescription drug market. 

In the United States, about 6.4 million, or 11 percent, of children and adolescents ages 4 to 17 have been diagnosed with ADHD. In this group, 80 percent receive treatment and 65 percent demonstrate ADHD symptoms into adulthood. 

An estimated 4.4 percent (11 million) of adults have ADHD — double the size of the child and adolescent segment combined — but only 20 percent receive treatment. The adult market is growing at 10 percent annually as more patients seek treatment. 

In December, Cingulate raised $25 million through an initial public stock offering on NASDAQ listed as CING. 

This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice.

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