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0 Diseases |  |
2 Trials |
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2 Trials |  |
61 News |  |
- Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Trial completion, Trial completion date, Trial primary completion date: Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening (clinicaltrials.gov) - Oct 1, 2024
P4, N=29, Completed, Sponsor: NYU Langone Health
Recruiting --> Completed | Trial completion date: Feb 2025 --> Jul 2024 | Trial primary completion date: Dec 2024 --> Jul 2024
- || Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Enrollment closed, Trial completion date, Trial primary completion date: KP415P02: A Safety/Tolerability and PK Study With Azstarys (clinicaltrials.gov) - Aug 1, 2024
P4, N=123, Active, not recruiting, Sponsor: Corium, Inc.
Recruiting --> Completed | Trial completion date: Feb 2025 --> Jul 2024 | Trial primary completion date: Dec 2024 --> Jul 2024 Recruiting --> Active, not recruiting | Trial completion date: Mar 2025 --> Jul 2025 | Trial primary completion date: Mar 2025 --> Jul 2025
- |||| Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Trial completion: KP415P01: An Efficacy and Safety Study w/ Azstarys (clinicaltrials.gov) - Jul 12, 2024
P4, N=246, Completed, Sponsor: Corium, Inc.
Recruiting --> Active, not recruiting | Trial completion date: Mar 2025 --> Jul 2025 | Trial primary completion date: Mar 2025 --> Jul 2025 Active, not recruiting --> Completed
- ||| Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Enrollment closed: KP415P01: An Efficacy and Safety Study w/ Azstarys (clinicaltrials.gov) - Apr 23, 2024
P4, N=246, Active, not recruiting, Sponsor: Corium, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||| Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
New P3 trial: A Study to Evaluate the Efficacy, Safety and Tolerability of Oral AK0901 in Children With ADHD (clinicaltrials.gov) - Apr 11, 2024
P3, N=50, Not yet recruiting, Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.
- | Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Journal: Serdexmethylphenidate/dexmethylphenidate for children with attention-deficit/hyperactivity disorder: dose optimization from a laboratory classroom study. (Pubmed Central) - Apr 3, 2024
SDX/d-MPH demonstrated significant reductions in ADHD severity in children based on the Conners 3rd Edition-Parent scores. Determining the optimal dosage of SDX/d-MPH and its effect on ADHD severity could enable the development of a more clinically relevant treatment regimen in children with ADHD.
- Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Enrollment open: Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening (clinicaltrials.gov) - Sep 18, 2023
P4, N=30, Recruiting, Sponsor: NYU Langone Health
Determining the optimal dosage of SDX/d-MPH and its effect on ADHD severity could enable the development of a more clinically relevant treatment regimen in children with ADHD. Not yet recruiting --> Recruiting
- | Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
New P4 trial: Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening (clinicaltrials.gov) - Aug 21, 2023
P4, N=30, Not yet recruiting, Sponsor: NYU Langone Health
- | Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Journal: Serdexmethylphenidate/dexmethylphenidate effects on sleep in children with attention-deficit/hyperactivity disorder. (Pubmed Central) - Jul 10, 2023
P3
In this analysis of children taking SDX/d-MPH for ADHD, sleep problems did not worsen based on the mean CSHQ total sleep disturbance score. Statistically significant improvements in most CSHQ sleep domains were observed after 1 month and lasted for up to 12 months of treatment.
- ||| Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Enrollment open: KP415P02: A Safety/Tolerability and PK Study With Azstarys (clinicaltrials.gov) - May 26, 2023
P4, N=100, Recruiting, Sponsor: Corium, Inc.
Statistically significant improvements in most CSHQ sleep domains were observed after 1 month and lasted for up to 12 months of treatment. Not yet recruiting --> Recruiting
- | Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Journal: Analysis of Growth Velocity in Children with Attention-Deficit/Hyperactivity Disorder Treated for up to 12 Months with Serdexmethylphenidate/Dexmethylphenidate. (Pubmed Central) - May 23, 2023
P3
The overall effects of SDX/d-MPH on growth velocity (the change in weight and height from one time point to the next) were minimal, and the range of changes was not considered clinically significant. ClinicalTrials.gov identifier: NCT03460652.
- A Comprehensive Review of Novel FDA Approved Psychiatric Indications From 2018-2022 (Hall B Foyer, Exhibition Level Moscone South) - May 17, 2023 - Abstract #APA2023APA_968;
Clinical trials for each medication suggested favorable results in Phase III trials that lead to approval, along with current success in Phase IV trials as well. In 2018, Lucemyra (lofexidine) was approved for the treatment of opioid withdrawal.
- | Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Journal: Safety and Tolerability of Serdexmethylphenidate/Dexmethylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder: A 12-Month, Open-Label Safety Study. (Pubmed Central) - Mar 24, 2023
P3
SDX/d-MPH also showed sustained efficacy during the 1-year treatment period. ClinicalTrials.gov identifier: NCT03460652.
- |||| Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Enrollment open: KP415P01: An Efficacy and Safety Study w/ Azstarys (clinicaltrials.gov) - Feb 22, 2023
P4, N=230, Recruiting, Sponsor: Corium, Inc.
ClinicalTrials.gov identifier: NCT03460652. Not yet recruiting --> Recruiting
- | Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Azstarys looking meaningful with backups? (Twitter) - Feb 20, 2023
- |||| Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
New P4 trial: KP415P02: A Safety/Tolerability and PK Study With Azstarys (clinicaltrials.gov) - Feb 9, 2023
P4, N=100, Not yet recruiting, Sponsor: Corium, Inc.
- ||||| Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
New P4 trial: KP415P01: An Efficacy and Safety Study w/ Azstarys (clinicaltrials.gov) - Jan 17, 2023
P4, N=230, Not yet recruiting, Sponsor: Corium, Inc.
- Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) Optimized Dose Levels and Effects on Attention-deficit/hyperactivity Disorder-rating scale-5 (ADHD-RS-5) Response Rates in Children with ADHD (Anaheim Convention Center, Hall A, Board # 019) - Nov 10, 2022 - Abstract #AAPNCE2022AAP_NCE_2370;
P3
Not yet recruiting --> Recruiting This analysis showed that responders are evident after the first week of treatment at the 26.1-/5.2-mg and 39.2-/7.8-mg final dose levels, with small increases in the proportion of responders thereafter, whereas the 52.3-/10.4-mg final dose level continued to notably increase in the proportion of responders after titration to the 52.3-/10.4-mg final dose level.
- | Vyvanse (lisdexamfetamine) / Shionogi, Takeda, Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Journal: New Drugs to Treat ADHD: Opportunities and Challenges in Research and Development. (Pubmed Central) - Aug 7, 2022
Since the landmark MTA (Multimodal Treatment of ADHD) trial unequivocally demonstrated the efficacy of methylphenidate, catecholaminergic drugs, especially stimulants, have been the therapeutic mainstay in treatment of Attention-Deficit Hyperactivity Disorder (ADHD)...The substantial number of failures probably accounts for a continued focus on developing novel catecholaminergic and noradrenergic drugs, and a dearth of drug-candidates with novel mechanisms entering clinical development. However, substantial improvements in ADHD pharmacotherapy have been achieved by the almost exclusive use of once-daily medications and prodrugs, e.g. lisdexamfetamine and Azstarys, which improve compliance, deliver greater efficacy and reduce risks for diversion and abuse.
- || Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Clinical, Journal: Oral, intranasal, and intravenous abuse potential of serdexmethylphenidate, a novel prodrug of d-methylphenidate. (Pubmed Central) - Jul 9, 2022
Adverse events typical of stimulants were more frequent with d-MPH than SDX. These findings indicate that the novel d-MPH prodrug, SDX, has lower abuse potential than d-MPH and support its classification as a C-IV controlled substance.
- || Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
PK/PD data, Journal: Dose Proportionality and Steady-State Pharmacokinetics of Serdexmethylphenidate/Dexmethylphenidate, a Novel Prodrug Combination to Treat Attention-Deficit/Hyperactivity Disorder. (Pubmed Central) - Jun 22, 2022
The PK profile of SDX/d-MPH is characterized by a rapid rise and a gradual decline in d-MPH concentration, with proportional C and AUC across doses. The PK attributes of SDX/d-MPH may optimize symptom control from early morning to early evening, while the demonstrated dose proportionality may facilitate initial dose titration and ongoing dose adjustment.
- || Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
our princess surprises us more every day we are proud of you and grateful to Science AZSTARYS 🙏 focus calm ♥️ (Twitter) - Jan 18, 2022
- Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Single-Dose Pharmacokinetics Of Serdexmethylphenidate/D-Methylphenidate Capsules In Children And Adolescents With Adhd And Healthy Adults: An Evaluation Of Age And Body Weight () - Dec 18, 2021 - Abstract #AACAP2021AACAP_704;
A nonlinear regression model indicated a moderate correlation (R2 = 0.628) between d-MPH CL/F and BW. In adults (study 2), the shape of the PK curve was comparable to those obtained in children and adolescents when administered under the same conditions.Conclusions BW is an appropriate scaling factor for d-MPH exposure after oral SDX/d-MPH dosing in children, adolescents, and adults.ADHD
- || Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Clinical, Journal: A Randomized, Controlled Laboratory Classroom Study of Serdexmethylphenidate and d-Methylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder. (Pubmed Central) - Dec 16, 2021
SDX/d-MPH showed significant improvement in ADHD symptoms compared with placebo in children 6-12 years of age, with a rapid onset and extended duration of treatment effect. SDX/d-MPH was safe, with AEs comparable with those observed with other stimulant treatments.
- ||| Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
$KMPH AZSTARYS®, An Innovative ADHD Treatment Developed by KemPharm, to be Featured in a Poster Presentation at the 2021 Psych Congress https://t.co/jIj5pytlPQ (Twitter) - Oct 27, 2021
- | Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Journal: Azstarys (serdexmethylphenidate/dexmethylphenidate) for ADHD. (Pubmed Central) - Oct 7, 2021
SDX/d-MPH was safe, with AEs comparable with those observed with other stimulant treatments. No abstract available
- serdexmethylphenidate oral (KP415 oral) / Corium
[VIRTUAL] Oral, Intranasal, and Intravenous Abuse Potential of Serdexmethylphenidate, a Novel Prodrug of d-Methylphenidate () - Dec 6, 2020 - Abstract #APSARD2021APSARD_177;
Abuse-related subjective measures, plasma samples, and safety data were collected. Studies were conducted in accordance with FDA Guidance on abuse potential (2017).
- | Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Trial completion: KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD (clinicaltrials.gov) - Aug 18, 2019
P3, N=282, Completed, Sponsor: KemPharm, Inc.
Studies were conducted in accordance with FDA Guidance on abuse potential (2017). Recruiting --> Completed
- |||| Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Trial completion date, Trial primary completion date: KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD (clinicaltrials.gov) - Apr 22, 2019
P3, N=250, Recruiting, Sponsor: KemPharm, Inc.
Recruiting --> Completed Trial completion date: Mar 2019 --> Jun 2019 | Trial primary completion date: Mar 2019 --> Jun 2019
- | Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Trial completion: KP415 Classroom Study in Children (6-12 Years of Age) With ADHD (clinicaltrials.gov) - Jun 14, 2018
P3, N=157, Completed, Sponsor: KemPharm, Inc.
Trial completion date: Mar 2019 --> Jun 2019 | Trial primary completion date: Mar 2019 --> Jun 2019 Active, not recruiting --> Completed
- | Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Enrollment closed: KP415 Classroom Study in Children (6-12 Years of Age) With ADHD (clinicaltrials.gov) - Apr 9, 2018
P3, N=140, Active, not recruiting, Sponsor: KemPharm, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Enrollment open: KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD (clinicaltrials.gov) - Apr 8, 2018
P3, N=250, Recruiting, Sponsor: KemPharm, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
New P3 trial: KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD (clinicaltrials.gov) - Mar 9, 2018
P3, N=250, Not yet recruiting, Sponsor: KemPharm, Inc.
- | Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Trial completion date, Trial primary completion date: KP415 Classroom Study in Children (6-12 Years of Age) With ADHD (clinicaltrials.gov) - Mar 3, 2018
P3, N=140, Recruiting, Sponsor: KemPharm, Inc.
Not yet recruiting --> Recruiting Trial completion date: Feb 2018 --> Apr 2018 | Trial primary completion date: Feb 2018 --> Apr 2018
- | Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
Enrollment open: KP415 Classroom Study in Children (6-12 Years of Age) With ADHD (clinicaltrials.gov) - Dec 7, 2017
P3, N=140, Recruiting, Sponsor: KemPharm, Inc.
Trial completion date: Feb 2018 --> Apr 2018 | Trial primary completion date: Feb 2018 --> Apr 2018 Not yet recruiting --> Recruiting
- | Azstarys (serdexmethylphenidate/dexmethylphenidate oral) / Corium
New P3 trial: KP415 Classroom Study in Children (6-12 Years of Age) With ADHD (clinicaltrials.gov) - Sep 26, 2017
P3, N=140, Not yet recruiting, Sponsor: KemPharm, Inc.