BOSTON, June 26, 2023 /PRNewswire/ -- Corium, LLC, a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today that the peer-reviewed journal Frontiers in Psychiatry published an analysis of a yearlong open-label safety study of Corium's attention-deficit hyperactivity disorder (ADHD) medicine AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]). AZSTARYS was approved by the U.S. Food and Drug Administration in 2021 for the treatment of ADHD symptoms in people aged 6 years through adulthood. The analysis showed that study participants, children aged 6 to 12 years with ADHD and treated with AZSTARYS for up to twelve months, had statistically significant and lasting improvements in their sleep as assessed by the Children's Sleep Habits Questionnaire (CSHQ), a caregiver-reported screening survey designed to assess behavioral and medically based sleep problems in school children.
BOSTON , May 22, 2023 /PRNewswire/ -- Corium, LLC, a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced that an analysis of a long-term, 12-month, open-label Phase 3 study of children aged 6-12 using its novel attention-deficit hyperactivity disorder (ADHD) medication AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) showed no clinically significant impact on weight and height growth rate in pediatric patients. CNS stimulants prescribed for treatment of ADHD have been associated with slowing of height and weight growth in pediatric patients. The study results were published in the peer-reviewed Journal of Child and Adolescent Psychopharmacology (JCAP).
BOSTON, March 13, 2023 /PRNewswire/ -- Corium, LLC, a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announces the upcoming presentation of positive data about its first-in-class attention deficit hyperactivity disorder (ADHD) medicine AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) at two national medical association meetings this month.
BOSTON, Feb. 22, 2023 /PRNewswire/ -- Corium, LLC, a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today publication of the results from a 12-month, open-label, phase 3 safety study of AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]), which is indicated for treatment of attention-deficit hyperactivity disorder (ADHD) in people ages six and older. Published in the peer-reviewed Journal of Child and Adolescent Psychopharmacology (JCAP), the results show that AZSTARYS provided sustained symptom improvement and was well-tolerated in children aged 6 to 12 who participated in the study. AZSTARYS was approved by the U.S. FDA in March 2021 and has recently been launched nationally by Corium.
Boston, MA, September 21, 2022 — Corium, Inc., a fully integrated biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced publication of a poster, “Serdexmethylphenidate/Dexmethylphenidate Effects on Sleep in Children With Attention Deficit Hyperactivity Disorder,” at the Psych Congress 2022 in New Orleans. The poster presented an analysis of the twelve-month open label safety study in children ages 6-12 using AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]), which is indicated for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients six and older. The data showed that the children, after one month of taking AZSTARYS, had statistically significant improvement in their sleep as assessed by the Children's Sleep Habits Questionnaire (CSHQ). The improvement in sleep was sustained through 12 months of treatment with AZSTARYS.
Boston, MA, September 13, 2022 — Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announces the debut of positive data on September 18, 2022, at the upcoming Psych Congress 2022 in New Orleans about its two FDA-approved medicines, AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) for patients six and older with ADHD, and ADLARITY (donepezil transdermal system) for patients with mild, moderate, or severe dementia of the Alzheimer's type.
Boston, MA, June 1, 2022 — Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced that serdexmethylphenidate (SDX), the novel prodrug of dexmethylphenidate (d‑MPH), has significantly lower potential for abuse and fewer stimulant-like adverse events compared to d‑MPH. This peer-reviewed finding appears in the May 2022 publication of Current Medical Research & Opinion. AZSTARYS (serdexmethylphenidate and dexmethylphenidate) is the first and only medicine containing SDX and was approved by the U.S. FDA in March 2021 as a once-daily treatment for ADHD symptoms in patients aged 6 years and older.
Boston, MA, March 28, 2022 — Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced that its poster, “Serdexmethylphenidate/d-Methylphenidate Capsules for Children With ADHD: Effects on SKAMP‑C Evaluated Over 13 Hours in a Randomized, Double-blind, Placebo-controlled Laboratory Classroom Study,” will be presented at the Academy of Managed Care Pharmacy (AMCP) on March 30, 2022, in Chicago, IL. Corium’s once‑daily oral capsule AZSTARYS (serdexmethylphenidate (SDX) and dexmethylphenidate (d‑MPH)), significantly improved both attention and behavior with a 30‑minute onset and up to 13 hours of duration in children ages 6 to 12 years diagnosed with attention deficit hyperactivity disorder (ADHD), compared to a placebo. An author will report the findings (poster # F21), from a post hoc analysis of a pivotal Phase 3 study, at the AMCP.
Boston, MA, October 29, 2021 - Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced publication of results from its Phase 3 pivotal efficacy study in the November 2021 Journal of Child and Adolescent Psychopharmacology. The study showed that Corium's first-in-class, once-daily oral capsule AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) significantly improved attention deficit hyperactivity disorder (ADHD) symptoms compared to placebo in children ages 6 to 12 years with a 30-minute onset, 13-hour duration of efficacy, and well-tolerated safety profile comparable to that observed with other stimulant medications. Data from this study will be presented at CHADD's Virtual International Conference on ADHD.
Boston, MA, October 14, 2021 - Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today its first-in-class once-daily oral capsule AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]), which was approved by the U.S. Food and Drug Administration (FDA) in March 2021, significantly reduced attention deficit hyperactivity disorder (ADHD) symptoms in children ages 6 to 12 years during a phase 3 controlled classroom clinical trial. The results are being presented in a poster and a Meet the Presenter session on October 15, 2021, during the American Psychiatric Nurses Association (APNA) 35th Annual Conference, held virtually on October 13-16. AZSTARYS is the first and only medicine to add the innovative SDX prodrug with d-MPH.
Boston, July 21, 2021 (PR NEWSWIRE) - Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announces that the innovative AZSTARYS™ (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]), is now available in the U.S. for the treatment of attention deficit hyperactivity disorder (ADHD) symptoms in patients aged 6 years and older.
Boston, MA, March 3, 2021 (PR NEWSWIRE) - 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 AZSTARYS™ (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH])…
