Launch of OLPRUVA® underway Topline results from KP1077 phase 2 study demonstrate clinically meaningful benefits for key IH symptoms Q4 2023 net revenue of $13.2M, and FY 2023 net revenue of $27.5M ...
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, 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.
CELEBRATION, Fla., Nov. 18, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a biotechnology company focused on the discovery, development and commercialization of novel treatments for rare central nervous system (CNS) and neurodegenerative diseases, lysosomal storage disorders and related treatment areas, today announced that the U.S. Food and Drug Administration (FDA) has granted the Orphan Drug Designation to serdexmethylphenidate (SDX), KemPharm’s proprietary prodrug of d-methylphenidate (d-MPH), for the treatment of idiopathic hypersomnia (IH), a rare neurological sleep disorder.
BOSTON, Sept. 13, 2022 /PRNewswire/ -- 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, June 1, 2022 /PRNewswire/ -- 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.
Data demonstrate higher doses of SDX were generally well-tolerated and produced targeted pharmacodynamic effects that may be beneficial for the treatment of idiopathic hypersomnia (IH) and other sleep...
CELEBRATION, Fla., Jan. 11, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced today that research involving serdexmethylphenidate (SDX), the company’s proprietary prodrug of d-methylphenidate (d-MPH), will be featured in two poster presentations during the American Professional Society of ADHD and Related Disorders 2022 Annual Conference (APSARD 2022) being held virtually January 13-16, 2022. Both posters will be presented by Rene A. Braeckman, Ph.D., Vice President, Clinical Development for KemPharm and will be accessible to registered meeting attendees beginning January 13th.