Attention-deficit/hyperactivity disorder (ADHD) is a clinically heterogenous neurodevelopmental disorder with high rates of comorbidity with other childhood-onset psychiatric disorders as well as learning disorders. As a result, pipeline products capable of targeting both ADHD and comorbid symptoms will have a competitive edge to capture a highly saturated ADHD market, says GlobalData.
Among the comorbidities associated with ADHD, key opinion leaders (KOLs) interviewed by GlobalData noted anxiety disorder, depression, and tic disorder as potentially affecting their treatment choices.
In a survey*** of 125 high prescribers across the 7MM* conducted by GlobalData, the rates of comorbid anxiety disorder were overall highest at 21.7 per cent and 28.3 per cent for pediatric and adult ADHD patients, respectively. For the adult ADHD population, this was followed by the rate of comorbid depression at 27.8 per cent. On the other hand, rates of comorbid tic disorder were lower but remained significant at 17.6 per cent in the pediatric population and 17.5 per cent in the adult population.
While stimulant medications such as methylphenidate are first-line pharmacotherapies in the treatment of ADHD in the 7MM, KOLs expressed a hesitancy to prescribe stimulants where the patient has comorbidities of anxiety and tic disorder.
According to a 5EU** KOL, in a quarter of patients comorbid for ADHD and tic disorder, there is a worsening of tics under treatment with stimulants. In these instances, Intuniv is often prescribed but there remains a demand for alterative medications.
Lorraine Palmer, Pharma Analyst at GlobalData, comments: “Intuniv alone is not sufficient to deal with all cases of comorbid anxiety, depression, or tic disorders. It has weaknesses in its efficacy against core ADHD symptoms, with KOLs stating that it can take up to three weeks to kick-in. In addition, it is not approved for use in adult populations or in Italy generally.”
There are currently four ADHD pipeline agents within late-stage development in the 7MM: Otsuka’s centanafadine SR, Axsome Therapeutic’s solriamfetol, Neurocentria’s NRCT-101SR (L-Threonate magnesium salt), and Cingulate’s CTx-1301 (dexmethylphenidate). Among these some are showing early potential to address anxiety and depression comorbidity.
|n a Phase I trial, NRCT-101SR showed an improvement in mood status including a reduction in anxiety and depression symptoms in patients with ADHD. Both solriamfetol and centanafadine SR are also pipeline agents in development for major depressive disorder; with a planned Phase III trial for solriamfetol and an ongoing Phase II trial for centanafadine SR.
However, there remains an opportunity to investigate the efficacy of these products in patients with ADHD and comorbid mood disorder. CTx-1301 is currently under investigation for the treatment of ADHD, with no found efficacy on comorbid disorders.
Palmer concludes: “With the prescriber survey showing clinically significant rates of comorbidity between ADHD, anxiety disorder, tic disorder, and depression, and KOLs describing their clinical experience of comorbidity with ADHD being as high as 80 per cent, there is a strong opportunity for capturing market share for any medication which can address these comorbidities.”
*7MM: France, Germany, Italy, Spain, the UK, the US, and Japan.
**5EU countries: France, Germany, Italy, Spain and the UK.
***2024 ADHD high prescriber survey: GlobalData surveyed 125 high-prescribing physicians, who represented the 7MM. The survey was launched in January and completed in February 2024