ORADUR®-Methylphenidate ER Capsule Achieves Primary Endpoint in Phase 3 Study in ADHD in Taiwan
8:30 am ET August 8, 2017 (PR Newswire) Print
CUPERTINO, Calif., Aug. 8, 2017 /PRNewswire/-- DURECT Corporation (Nasdaq: DRRX) today announced that Orient Pharma Co., Ltd., its licensee for certain Asian and South Pacific countries, has informed DURECT that a Phase 3 clinical study of ORADUR-Methylphenidate ER Capsule conducted in Taiwan has achieved positive results. ORADUR-Methylphenidate ER Capsule is an investigational drug candidate for the treatment of attention deficit hyperactivity disorder (ADHD).
"We congratulate Orient Pharma on the results of this trial and look forward to their pursuing a new drug application with the Taiwan Food and Drug Administration," said James E. Brown, President and CEO of DURECT Corporation. "On our part, we intend to reach out with this Phase 3 data to potential development and commercialization partners for major markets not licensed to Orient Pharma."
The Study
This was a Phase 3, multi-center, randomized, double-blind, placebo controlled, two-way cross-over study designed to demonstrate the efficacy and safety of ORADUR-Methylphenidate ER Capsule in children and adolescents with ADHD aged 6 to 18 years. There were 110 subjects enrolled in this study, of which 99 evaluable subjects completed the study. The primary efficacy measure in this study was to demonstrate superiority of ORADUR-Methylphenidate ER Capsule over placebo using the Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form score. The SNAP-IV rating scale contains 26 questions, classified as three components of ADHD symptoms (inattention, hyperactivity/impulsivity and oppositional defiant disorder).
For the primary efficacy endpoint, ORADUR-Methylphenidate ER Capsule was superior to placebo in a statistically significant manner (p=0.0044 for the intent to treat population and p=0.0032 for the per protocol population).
There were no serious adverse events in this pivotal study. Orient Pharma's safety analysis indicates that the incidence of adverse events was generally consistent with other ADHD products.
About Attention Deficit Hyperactivity Disorder (ADHD)ADHD is a neurobehavioral condition that is estimated to affect over 5 million (approximately 9%) of U.S. children ages 3-17, according to the U.S. Department of Health and Human Services. The prevalence of ADHD in Taiwan has been reported to be approximately 5-7% among school children. The principal characteristics of ADHD are inattention, hyperactivity, and impulsivity. The condition presents itself in childhood and can be life long as a significant number of children with ADHD continue to present symptoms as adults. It is estimated that over 50% of children with ADHD in the U.S. are being treated by medication, with stimulants such as amphetamine or methylphenidate as first-line treatments. U.S. sales of ADHD treatments were approximately $10.4 billion in 2016. The 2010 National Survey on Drug Use & Health estimates that 1.1 million Americans over the age of 12 abuse stimulants for euphoric highs and increased performance or wakefulness.
About ORADUR(R)-Methylphenidate ER Capsule
ORADUR-Methylphenidate ER Capsule is an investigational product candidate for the treatment of ADHD. This drug candidate is intended to provide once-a-day dosing with added tamper-resistant characteristics to address common methods of abuse and misuse of methylphenidate, a commonly prescribed first-line treatment for ADHD. ORADUR-Methylphenidate ER Capsule is a drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration, the Taiwan Food and Drug Administration or other health authorities.
In August 2009, DURECT entered into a development and license agreement with Orient Pharma, a diversified multinational pharmaceutical, healthcare and consumer products company with headquarters in Taiwan, under which we granted to Orient Pharma development and commercialization rights in certain defined Asian and South Pacific countries to ORADUR-Methylphenidate ER Capsule. We retain rights to North America, Europe, Japan and all other countries not specifically licensed to Orient Pharma. If commercialized, we will be entitled to receive a royalty on sales of ORADUR-Methylphenidate ER Capsule by Orient Pharma. Orient Pharma has committed to supply a portion of our commercial requirements in territories other than the United States for ORADUR-Methylphenidate ER Capsule.
About ORADUR(R) Technology
ORADUR is a proprietary technology designed to transform short-acting oral capsule dosage forms into sustained release oral products, with the added potential benefit of resisting common methods of prescription drug misuse and abuse compared to other controlled release dosage forms on the market today.
