The treatment for attention deficit hyperactivity disorder (ADHD) patients is in short supply. Recently, the number of patients has sharply increased, but it has been mistakenly reported as a medication that helps enhance concentration for studying, leading to an increase in general demand, particularly in the academic circles of Daechi-dong. Consequently, it has been said that patients who genuinely need the medication are suffering. Experts note that when adolescents who do not have ADHD take this medication, they may exhibit impulsivity and aggression, along with a dangerous increase in drug dependence. The government has also begun reviewing misuse.
◇ Serious side effects when non-ADHD patients take medication
The number of patients prescribed ADHD medications has been sharply increasing in the past five years. According to the Ministry of Food and Drug Safety (MFDS) on the 26th, the number of ADHD patients who received prescriptions for methylphenidate-based treatments last year reached 337,595. This is nearly three times higher than the 143,470 reported in 2020. Among all patients prescribed last year, the number of teenagers was approximately 153,030, close to half.
Currently, over 80% of the domestic ADHD treatment market consists of methylphenidate-based medications. Methylphenidate is classified as a controlled substance. The most representative drug among them is "Concerta," developed by Janssen, a subsidiary of Johnson & Johnson in the U.S. It is used to treat symptoms such as attention deficit and hyperactivity in children and adolescents aged 6 and older. Its long-lasting effects, when taken once a day, lead to frequent prescriptions.
"Concerta" has recently become hard to find as supply has not kept up with demand. Whan In Pharm reported to the MFDS three times about the supply shortage of Concerta in April and July of last year, and in February of this year. Industry insiders believe that Janssen has recently increased production at its U.S. factory, and supply is expected to stabilize by the end of May.
Due to the scarcity of Concerta, alternative medications with the same active ingredient are also gaining attention. Among domestic pharmaceutical companies, Whan In Pharm and Myungjin Pharmaceutical are selling ADHD treatments "Phenid" and "Medikinet Retard," which both contain methylphenidate. Of the 15 ADHD treatments licensed in Korea so far, 7 have either expired, been withdrawn, or canceled, exiting the market. The products currently available are all from Myungjin Pharmaceutical and Whan In Pharm, aside from Janssen.
The MFDS has stated that, apart from the supply shortage, it will strengthen monitoring and on-site inspections to ensure that methylphenidate is prescribed according to misuse prevention guidelines. This comes after reports circulated in the education sector that Concerta is misused as a drug to improve concentration. Concerta is a controlled substance with significant risk for side effects.
Professor Chun Geun-a of the pediatric psychiatry department at Severance Hospital remarked, "When a normally developing child with a functioning dopamine system takes ADHD medication, the cognitive enhancement effect is minimal. Instead, they may experience problems with emotional regulation, leading to impulsivity or aggression, excessive anxiety, decreased concentration, and, in rare cases, hallucinations, ultimately resulting in dependency on the medication." Professor Chun emphasized that medical institutions should pay attention to thoroughly checking childhood history and understanding symptoms in various environments, not just relying on computerized attention tests when diagnosing ADHD in teenage patients.
The MFDS has established three criteria for addressing misuse prevention measures: when prescriptions and dosages exceed three months; when prescriptions and dosages are for symptoms beyond ADHD or narcolepsy; and when prescriptions and dosages exceed daily maximum allowable quantities. The MFDS plans to take strong action against online false and exaggerated advertisements, including those promoting a "study-enhancing drug."
◇ A glimmer of hope for SK Biopharm's "Sunosi" in Phase 3 trials
As the number of ADHD patients surges, efforts to break Concerta's dominance are also gaining momentum. Whan In Pharm and Myungjin Pharmaceutical have developed and are selling generics of "Strattera," a non-stimulant ADHD treatment developed by Eli Lilly, which exited the South Korean market at the end of last year.
The possibility of developing alternative new drugs is also increasing. A representative example is "Sunosi" (solriamfetol), a sleep disorder treatment exported to the U.S. by SK Biopharm in 2011. The rights to Sunosi have passed through Aerial Biopharma and Jazz Pharmaceuticals to Axovant Gene Therapies. Axovant is conducting clinical trials to expand Sunosi's indication to include ADHD.
According to Axovant's announcement on the 25th (local time), positive results from Phase 3 trials on adult ADHD patients have opened the door for U.S. Food and Drug Administration (FDA) approval. Sunosi is not a controlled substance like methylphenidate. It is a norepinephrine-dopamine reuptake inhibitor, which works by increasing the levels of dopamine and norepinephrine, leading to attention and wakefulness effects.
Axovant plans to conduct additional clinical trials targeting pediatric ADHD patients within the year. Solriamfetol is also being developed as a treatment for major depressive disorder (MDD), binge eating disorder (BED), and shift work sleep disorder (SWSD). If approved by the FDA in the future, the possibility of domestic introduction is anticipated. SK Biopharm holds the rights to Sunosi in 12 Asian countries.
An electronic ADHD medication is also under development. The domestic company Newin received 510(k) approval from the U.S. FDA for "SMILE," an electronic ADHD medication that stimulates the brain, in November last year. The 510(k) is a certification system that verifies that a device has greater efficacy and safety compared to existing marketed devices.