Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today the U.S. Food and Drug Administration (FDA) approval of once-daily oral capsule AZSTARYSTM
BOSTON, March 3, 2021 /PRNewswire/ -- Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today the U.S. Food and Drug Administration (FDA) approval of once-daily oral capsule AZSTARYSTM (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]), the first and only product containing a d-MPH oral prodrug for the treatment of attention deficit hyperactivity disorder (ADHD) symptoms in patients aged 6 years and older. The FDA approval of AZSTARYS means Corium is one step closer to bringing this innovative therapy to market AZSTARYS contains 30 percent immediate-release d-MPH and 70 percent extended-release novel SDX, a prodrug of d-MPH. After absorption via the gastrointestinal tract, SDX is converted to d-MPH with a design to gradually release d-MPH throughout the day. The result is a therapy designed to provide symptom control both rapidly with the d-MPH and for an extended duration with SDX. The dual action of AZSTARYS is designed to address the unmet needs in the market, including early onset of action and long duration of therapy, with steady ADHD symptom control in one capsule. The Prescribing Information for AZSTARYS includes a Boxed Warning stating CNS stimulants, including AZSTARYS, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. “The data documenting the efficacy and safety of this new dual-action medicine, the first ever to use the novel prodrug serdexmethylphenidate together with d-methylphenidate, is welcome news for clinicians and families to consider when choosing an appropriate ADHD therapy for children,” said Ann Childress, M.D., president of the Center for Psychiatry and Behavioral Medicine and lead investigator of the pivotal AZSTARYS clinical trial. Corium, a wholly-owned portfolio company of Gurnet Point Capital (GPC), will be leading the U.S. commercialization activities for AZSTARYS. “The FDA approval of AZSTARYS means Corium is one step closer to bringing this innovative therapy to market and providing patients with ADHD and their clinicians a new option for rapid and extended symptom control via the dual action of d-MPH and the novel d-MPH prodrug SDX,” said Perry J. Sternberg, President and CEO of Corium. “The team at Corium is energized to leverage their deep ADHD and commercialization expertise to launch and market AZSTARYS, which is an important milestone for Corium and its focus on CNS therapies.” AZSTARYS Clinical Study Efficacy and Safety Data AZSTARYS was evaluated in a multicenter, double-blind, randomized, placebo-controlled, laboratory classroom phase 3 study in 150 children aged 6 to 12 years diagnosed with ADHD (NCT03292952). The results of this study were presented in January 2021 at the American Professional Society of ADHD and Related Disorders Annual Meeting. In this study, AZSTARYS significantly improved ADHD symptoms with a single dose, as measured by the primary endpoint, the change from baseline in Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale – Combined (SKAMP-C) scores averaged over a 13-hour laboratory classroom day. As ADHD symptoms improve, SKAMP-C scores decline. In the study, the improvements significantly differed for children treated with AZSTARYS compared to those receiving a placebo, with an average SKAMP-C score reduction of -5.4 points more in the AZSTARYS group [95% CI: (-7.1, -3.7)]. Adverse events (AEs) occurring more frequently in the AZSTARYS group (in 2 percent or more of the participants) compared to the placebo group were headache (5.4 vs. 1.3 percent, AZSTARYS and placebo respectively), upper abdominal pain (4.1 vs. 1.3 percent), insomnia (2.7 vs. 1.3 percent), and pharyngitis (sore throat) (2.7 vs. 0 percent). No serious AEs were reported in this study. Commonly reported (5 percent or more of the MPH group and at least twice the rate of the placebo group) adverse reactions from placebo-controlled trials of methylphenidate products include: decreased appetite, decreased weight, nausea, abdominal pain, dyspepsia, vomiting, insomnia, anxiety, affect lability, irritability, dizziness, increased blood pressure, and tachycardia. AZSTARYS Scheduling and Launch About ADHD Indication and Important Safety Information for AZSTARYS WARNING: AZSTARYS is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep AZSTARYS in a safe place to prevent misuse and abuse. Selling or giving away AZSTARYS may harm others and is against the law. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Who should not take AZSTARYS?
Serious problems can occur while taking AZSTARYS. Tell your healthcare provider:
What are possible side effects of AZSTARYS?
These are not all the possible side effects of AZSTARYS. Call your doctor for medical advice about side effects. What is AZSTARYS? For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. About Corium Corium President and CEO is Perry J. Sternberg, a biotechnology and pharmaceutical industry leader with more than 25 years of commercial experience across a wide range of therapeutic areas, including ADHD in diverse markets. Prior to joining Corium, Mr. Sternberg served a dual role at Shire Plc (Shire) as the Head of U.S. Commercial for seven therapeutic area business units, as well as the Chief Commercial Officer/Head of the Neuroscience Division, before the acquisition of Shire by Takeda Pharmaceutical Corporation Limited in early 2019. About Gurnet Point Capital Contact: SOURCE Corium, Inc. |