KANSAS CITY, Kan., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release„¢ (PTR„¢) drug delivery platform...
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.
Study Assessed Onset and Duration of CTx-1301 in Adults, Results Expected 3Q 2023 Pivotal Phase 3 Trials in Pediatric/Adolescent Patients on Schedule for 3Q 2023 Initiation KANSAS CITY, Kan., June ...
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).
KANSAS CITY, Kan., May 03, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Releaseâ„¢ (PTRâ„¢) drug delivery platform...
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, 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.
SHANGHAI, China, Dec. 28, 2021 (GLOBE NEWSWIRE) -- Shanghai Ark Biopharmaceutical Co., Ltd. (“ArkBio”), an innovative biopharmaceutical company with a depth of expertise in pediatric drug development, today announced that Ark Biopharmaceutical Limited, a wholly-owned subsidiary of ArkBio, entered into an exclusive license agreement with Commave Therapeutics, SA (Commave), an affiliate of Gurnet Point Capital (GPC), a private investment firm focused on the life sciences and medical technology sectors. The license agreement provides for exclusive rights to develop, manufacture, and commercialize the first-in-class once-daily attention deficit hyperactivity disorder (ADHD) treatment AZSTARYS® (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.