Pharmaceutical companies would do well to pay attention to the development of new treatments for ADHD, as there is a demand for improved medications in this space.
Currently, the medications of choice for this condition are stimulant drugs, such as Takeda (New York Stock Exchange: YES) Vyvanse (lisdexamfetamine) and Johnson & Johnson (JNJ) Janssen Concerta unit (methylphenidate). While effective, stimulant drugs have disadvantages. They are considered Schedule II controlled substances and have a risk of dependence and abuse.
Although there are non-stimulant medications on the market for ADHD, they are generally relegated to second-line treatments as their effectiveness is not as strong as that of stimulant medications.
A non-stimulant drug that can at least match the effectiveness of a stimulant drug for ADHD could present a significant opportunity for drugmakers, according to a new report from GlobalData.
“An additional competitive advantage for non-stimulants in development would be addressing comorbid symptoms common with ADHD, such as autism spectrum disorder and emotional instability,” said Lorraine Palmer, an analyst at GlobalData Pharma.
The good news is that three of the four late-stage ADHD medications are not stimulants. They are: solriamfetol from Axsome Therapeutics (NASDAQ:AXSM), centanafadin from Otsuka (OTCPK:OTSKF)(OTCPK:OTSKY) and magnesium l-threonate salt from the private company Neurocentria.
However, the consulting and analytics firm noted that based on feedback from key opinion leaders, non-stimulants are unlikely to overthrow stimulants as a first-line treatment for ADHD without equal efficacy. No face-to-face trials are taking place.
KOLs also identified the lack of dosing flexibility associated with non-stimulants as a problem. If this could be solved, new non-stimulant medications could provide a competitive advantage over currently marketed versions.
The only stimulant drug in phase 3 development mentioned in the Global data reportCTx-1301 from Cingulate (NASDAQ:CING), could become a first-line treatment rivaling currently available therapies if it can provide 16 hours of treatment coverage for each dose. Currently, only Takeda Pharmaceutical's (TAK) Mydayis ER (mixed amphetamine salts) lasts as long.
“The KOLs have stated that (CTx-1301) could become their option,” Palmer said. “However, long-term action carries the potential for sleep disturbances, such as delayed sleep onset. As KOLs consistently raise concerns about poor adherence to ADHD medication, the development of “A drug that provides coverage into the night without affecting sleep is a key unmet need.”