#China #Shanghai #Azstarys #ADHD treatment #Ark Biopharmaceutical

Ark Biopharmaceutical Gains Marketing Authorization for Azstarys® in China

In a landmark development for ADHD treatment in China, Ark Biopharmaceutical has announced that the National Medical Products Administration (NMPA) has approved its New Drug Application for Azstarys® (serdexmethylphenidate chloride and dexmethylphenidate hydrochloride capsules). This innovative medication is designed to effectively manage Attention Deficit Hyperactivity Disorder (ADHD) in patients aged six and older, offering a new therapeutic option in a market where alternatives have been scarce.

Overview of Azstarys®

Azstarys® is the first ADHD medication in China that combines immediate-release and prodrug technologies, providing both quick and sustained symptom control throughout the day. Each capsule contains 70% serdexmethylphenidate (SDX) and 30% dexmethylphenidate (d-MPH), allowing patients to experience rapid relief from ADHD symptoms upon ingestion. This novel formulation is particularly exciting in a landscape where treatment options are limited and often inadequate in efficacy and tolerability.

The immediate-release component ensures a swift onset of effect, while SDX is gradually converted to d-MPH, creating a dual mechanism that promises a comprehensive approach to ADHD management. This unique profile positions Azstarys® not only as a treatment option but also as a potential game-changer in the way ADHD is treated in China.

Understanding ADHD in China

ADHD, which typically manifests in childhood, is often characterized by varying degrees of inattention and hyperactivity-impulsivity. The disorder has a staggering prevalence, with estimates suggesting that around 6.4% of children and adolescents in China are affected, translating to over 23 million individuals. Unfortunately, a significant number of those diagnosed continue to experience symptoms into adulthood, suggesting a pressing need for effective and innovative treatment options in the region.

Current treatment practices in China face limitations; many existing medications fall short in meeting clinical requirements for efficacy and have unwanted side effects that lead patients to discontinue their usage. The launch of Azstarys® addresses this significant unmet need, potentially improving the treatment landscape for ADHD in the country.

Clinical Impact and Future Prospects

Clinical trials have demonstrated the effectiveness of Azstarys® in improving ADHD symptoms compared to placebo. In a pivotal Phase III study conducted in China, the drug achieved both primary and key secondary endpoints, showcasing substantial and statistically significant improvements across all assessment time points.

Professor Yi Zheng, a leading principal investigator of the clinical trial, emphasized the effect ADHD has on social functioning and learning in children. He noted the approval of Azstarys® provides clinicians with an indispensable new therapeutic option, especially for patients who have not responded well to existing treatments.

Moreover, there are heightened expectations around the medication's roll-out. Professor Jing Liu, another key figure in the clinical study, expressed hope that the introduction of Azstarys® will encourage a deeper investigation into ADHD treatment strategies in China. This reflects a broader commitment to enhancing both diagnosis and management of pediatric mental disorders across the nation.

Conclusion

Ark Biopharmaceutical's approval of Azstarys® marks an important milestone not only for the company but also for patients struggling with ADHD in China. The innovative dual-release technology is set to transform the management of ADHD, offering new hope to many who require effective treatment. With plans for commercial launch underway, Azstarys® is poised to enhance the options available for ADHD management, ultimately benefiting countless families and changing lives for the better.

For more information, you can visit Ark Biopharmaceutical’s official website at www.arkbiosciences.com.