DURECT Corp. announced that Orient Pharma Co., Ltd., its licensee for certain Asian and South Pacific countries, has informed DURECT that it has obtained marketing authorization from the Ministry of Health and Welfare in Taiwan for Methydur Sustained Release Capsules.
"Methydur Sustained Release Capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and will be available in three strengths (22 mg, 33 mg and 44 mg) in Taiwan," stated the company. "Orient Pharma also has stated that it expects to have Methydur Sustained Release Capsules commercially available in Taiwan in 2019, while seeking a partner in China and pursuing regulatory approvals in selected other countries where it has commercialization rights and a commercialization presence."
"We congratulate Orient Pharma on this new drug approval which will offer an alternative treatment for those patients suffering from ADHD in Taiwan," said James E. Brown, president and CEO of DURECT Corporation. "We are pleased to see this first marketing approval for a product utilizing the ORADUR technology and the second recent approval of a product utilizing our patents."
According to Orient Pharma, a phase 3, multi-center, randomized, double-blind, placebo controlled, two-way cross-over study designed to demonstrate the efficacy and safety of Methydur Sustained Release Capsules in children and adolescents with ADHD aged 6 to 18 years supported the new application.
"There were 110 subjects enrolled in this study, of which 100 evaluable subjects completed the study," stated the company. "For the primary efficacy endpoint, Orient Pharma observed a statistically significant difference between Methydur Sustained Release Capsules and Placebo treatments in the mean change of total score for the Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form."
Orient Pharma's conducted a safety analysis that indicates that the incidence of adverse events with Methydur Sustained Release Capsules was similar to other approved Methylphenidate products.
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