Recently, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that the New Drug Application (NDA) of Shanghai Aike Baifa's new drug Dexmethylphenidate Dexmethylphenidate Compound Capsules for the treatment of attention deficit hyperactivity disorder (ADHD) has been officially accepted. In April, the drug was included in the priority review by CDE. This means that this highly anticipated innovative ADHD drug is expected to significantly shorten the review cycle and enter the market ahead of schedule.

ADHD is not simply "naughty and hyperactive". As a chronic neurodevelopmental disorder, it is characterized by an imbalance in the transmission of neurotransmitters in the brain, which makes it difficult for patients to concentrate and control behavioral impulses. According to titration data, in 2021, the number of children aged 6-17 in China exceeded 24 million, with a prevalence of 1.7%. However, for a long time, clinical drug options have been extremely limited.
Ai Ke Baifa's design directly hits the above pain points, innovatively combining immediate-release dexmethylphenidate (d-MPH) with the prodrug silk dexmethylphenidate (SDX):

immediate-release component: takes effect within 30 minutes, helping children cope with immediate concentration needs such as morning classes;

prodrug conversion: SDX is slowly converted into active ingredients in the intestines, maintaining a stable blood concentration for 13 hours, covering all-day learning and social scenarios.

This "fast + long" biphasic release mechanism not only avoids the "roller coaster" of drug efficacy, but also significantly reduces the possibility of non-oral abuse because the prodrug needs to be converted in the body. The anti-abuse design in the pharmacokinetic dimension is unique among ADHD drugs worldwide.

The key support for the approval of silk dexmethylphenidate/dexmethylphenidate compound capsules in China this time comes from its solid local Phase III clinical data. The study was led by Professor Zheng Yi of Beijing Anding Hospital and Professor Liu Jing of Peking University Sixth Hospital, covering 8 research centers in China , and was conducted on children with ADHD aged 6-12 years old.

The results of the study are encouraging:

Effectiveness: significantly superior to placebo at all visit points, with statistically significant improvements in core symptoms (distraction, hyperactivity-impulsivity);

Safety: no drug-related serious adverse reactions were reported and the drug was well tolerated.
The treatment of ADHD has never been just a medical issue, but also about the restoration of social functions. Traditional medicines need to be taken at noon at school. Children resist being watched while taking medicine, and emotional breakdowns often occur in the afternoon after the effect of the medicine wears off. This kind of daily dilemma is exactly what compound preparations try to resolve. If a single dose of medicine can be achieved and cover the whole day, children do not need to take medicine at school, can still stay focused when doing homework in the evening, and their sleep will not be disturbed - this has far-reaching significance for the maintenance of children's self-esteem and the quality of family life.

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