Pharmaceutical companies would be wise to pay attention to developing new treatments for ADHD as there is a demand for improved drugs in the space.
Currently, the medications of choice for the condition are stimulant drugs, such as Takeda’s (NYSE:TAK) Vyvanse (lisdexamphetamine), and Johnson & Johnson (JNJ) unit Janssen’s Concerta (methylphenidate). While effective, the stimulant drugs have drawbacks. They are considered Schedule II controlled substances, and have a high risk for dependency and abuse.
Though there are non-stimulant drugs on the market for ADHD, they are usually relegated to second-line treatments as their efficacy is not as robust as stimulant meds.
A non-stimulant drug that can at least match the efficacy of a stimulant drug for ADHD could present a significant opportunity for drugmakers, according to a new report from GlobalData.
“A further competitive edge for pipeline non-stimulants would be to address the symptoms of co-morbidities common with ADHD, such as autism spectrum disorder and emotional instability,” noted GlobalData Pharma analyst Lorraine Palmer.
The good news is three out of the four ADHD drugs in late-stage development are non-stimulants. They are: solriamfetol from Axsome Therapeutics (NASDAQ:AXSM), centanafadine from Otsuka (OTCPK:OTSKF)(OTCPK:OTSKY), and l-threonate magnesium salt from privately held Neurocentria.
The consulting and analytical firm, however, noted that based on feedback from key opinion leaders, non-stimulants are unlikely to topple stimulants from their perch as the first-line ADHD treatment without the efficacy match. No head-to-head trials are underway.
KOLs also identified the lack of dosing flexibility associated with non-stimulants as an issue. If this could be addressed, new non-stimulant medications could provide a competitive edge over currently marketed versions.
The one stimulant medication in phase 3 development mentioned in the GlobalData report, CTx-1301 from Cingulate (NASDAQ:CING), could become a first-line treatment that rivals currently available therapies if it can provide 16 hours of treatment coverage for each dose. Only Takeda Pharmaceutical’s (TAK) Mydayis ER (mixed amphetamine salts), currently lasts as long.
“KOLs have stated (CTx-1301) might become their ‘go-to’,” Palmer said. “However, with a long duration of action comes the potential for sleep disturbances such as delayed sleep onset. Since poor compliance of ADHD medication is consistently raised as a concern by KOLs, the development of a drug that provides coverage into the evening without affecting sleep is a key unmet need.”