Benzinga | Jul 21, 2021 08:32AM EDT

KemPharm Announces U.S. Launch of ADHD Treatment AZSTARYS By Corium

KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced the U.S. commercial launch of AZSTARYS(tm), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older. Corium, Inc. (Corium), a portfolio company of Gurnet Point Capital (GPC), is leading the commercialization of AZSTARYS in the U.S.



AZSTARYS was approved by the U.S. Food and Drug Administration (FDA) in March 2021 and consists of serdexmethylphenidate (SDX), KemPharm's prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. Subsequent to the approval of AZSTARYS, SDX was classified as a Schedule IV controlled substance by the U.S. Drug Enforcement Administration (DEA). AZSTARYS is classified as a Schedule II controlled substance as it includes a 70:30 mixture of SDX (Schedule IV) and d-MPH (Schedule II).

"The U.S. commercial launch of AZSTARYS is a significant milestone for KemPharm and an important advancement in the treatment of ADHD, a disease indication that has seen little innovation in recent years," said Travis C. Mickle, Ph.D., President and CEO of KemPharm. "Since the FDA's approval of AZSTARYS in March, the various teams across Corium have been working diligently to ready AZSTARYS for its U.S. launch. We believe Corium has built a best-in-class commercial organization, and as a result, we expect the market potential for AZSTARYS will be maximized. It is great news that patients living with ADHD will now have a new treatment option with the potential to address previously unmet needs because of AZSTARYS' unique prodrug platform."

"The launch of AZSTARYS provides patients with ADHD, their caregivers, and their clinicians with a first-of-its-kind treatment that offers both rapid and extended ADHD symptom improvement because of the dual action of its formulation using the prodrug SDX with IR d-MPH," said Perry J. Sternberg, President and CEO of Corium. "We believe Corium's extensive ADHD and commercialization expertise will help ensure a successful AZSTARYS launch, and I am incredibly proud of our team for reaching this milestone, a significant inflection point in Corium's journey to become a leader in the CNS space."

Ann Childress, M.D., President of the Center for Psychiatry and Behavioral Medicine and an investigator in the AZSTARYS clinical trial, commented: "My decades of research in the ADHD space and treating patients with the condition has allowed me to be a firsthand witness to the evolution of ADHD drug development and implementation. Based on this perspective, I believe that AZSTARYS represents a true advance in ADHD medicine due to its unique combination of SDX, a prodrug of d-MPH, co-formulated with immediate release d-MPH, which provides both immediate release and consistent benefit throughout the course of the day. As a result, I believe AZSTARYS will soon become a drug of preference for physicians seeking to provide effective care for patients with ADHD."

About Attention Deficit Hyperactivity Disorder (ADHD):

Attention-deficit/hyperactivity disorder (ADHD) is one of the most common mental disorders affecting children. ADHD also affects many adults. Symptoms of ADHD include inattention (not being able to keep focus), hyperactivity (excess movement that is not fitting to the setting) and impulsivity (hasty acts that occur in the moment without thought).1 An estimated 8.4% of children and 2.5% of adults have ADHD.2,3

The U.S. ADHD market accounted for approximately $17.5 billion of revenue in 2019 with a year-over-year prescription growth rate greater than four percent (4%). Within this, the branded portion of the ADHD market was approximately $7.4 billion in 2019, with extended-release products representing more than 95% of the branded prescriptions. In 2019, the methylphenidate segment of the ADHD market accounted for approximately 20 million prescriptions and $4.9 billion in sales.