Korea Pharma said Thursday that it has submitted a new product license application to the Ministry of Food and Drug Safety (MFDS) for Methydur SR Cap (methylphenidate hydrochloride), a 24-hour long-acting treatment for attention deficit hyperactivity disorder (ADHD).
Methydur is a treatment for ADHD in children and adolescents developed by Orient Pharma in Taiwan. It is available in three dosage forms -- 22 mg, 33 mg, and 44 mg. In Taiwan, where it was developed, the drug underwent five phase 1 clinical trials. It completed a phase 3 study in 113 pediatric patients, demonstrating safety and efficacy, and won approval for marketing in 2018.
According to Korea Pharma, Methydur has won recognition for ORADUR technology, which reduces the side effects of drugs in the central nervous system (CNS) and significantly improves the risk of drug abuse. ORADUR controls the drug release rate while maintaining the characteristics of sustained-release formulations by filling the capsule with a gel-like, highly viscous liquid.
By introducing Methydur, which can be prescribed in various doses and has proven safety and effectiveness, Korea Pharma plans to overcome the current situation and provide patients with a stable drug supply environment.
"Obtaining Methydur's domestic marketing authorization will enable us to provide clinically improved treatments for the growing number of ADHD patients in Korea," Korea Pharma CEO Park Eun-hee said. “In addition, we expect that this treatment, combined with the ORADUR technology, will provide superior efficacy and protect pediatric patients from the risk of misuse of narcotic drugs, which has become a serious social problem in recent years."
Calvin Tsai, CEO of Orient Pharma Group in Taiwan, said that Methydur is the group’s second product to seek marketing authorization in Korea, and the company is honored to collaborate with Korea Pharma on this project.
"With a novel pharmacokinetic profile, we believe that our treatment will provide physicians and patients with a new treatment alternative while minimizing the risk of drug abuse, with a more effective drug release rate than other products in the current ADHD market," Tsai added.