Overview
Attention Deficit Hyperactivity Disorder (ADHD) is an early-onset neurodevelopmental disorder that often extends into adulthood and is characterized by developmentally inappropriate and impaired attention, impulsivity, and motor hyperactivity. The underlying cause of ADHD is unclear but likely involves dysfunction in dopaminergic and noradrenergic neurotransmission, as evidenced by the clear beneficial effect of CNS stimulants such as methylphenidate and amphetamine that increase extracellular dopamine and norepinephrine levels. Serdexmethylphenidate is a prodrug of the CNS stimulant dexmethylphenidate, a common first-line treatment for ADHD, that is combined with dexmethylphenidate to provide extended plasma concentrations and therapeutic benefit with once-daily dosing. Serdexmethylphenidate was granted FDA approval on March 2, 2021, and is currently marketed as a combination capsule with dexmethylphenidate under the trademark AZSTARYS™ by KemPharm, Inc.
Background
Attention Deficit Hyperactivity Disorder (ADHD) is an early-onset neurodevelopmental disorder that often extends into adulthood and is characterized by developmentally inappropriate and impaired attention, impulsivity, and motor hyperactivity. The underlying cause of ADHD is unclear but likely involves dysfunction in dopaminergic and noradrenergic neurotransmission, as evidenced by the clear beneficial effect of CNS stimulants such as methylphenidate and amphetamine that increase extracellular dopamine and norepinephrine levels. Serdexmethylphenidate is a prodrug of the CNS stimulant dexmethylphenidate, a common first-line treatment for ADHD, that is combined with dexmethylphenidate to provide extended plasma concentrations and therapeutic benefit with once-daily dosing. Serdexmethylphenidate was granted FDA approval on March 2, 2021, and is currently marketed as a combination capsule with dexmethylphenidate under the trademark AZSTARYS™ by KemPharm, Inc.
Indication
Serdexmethylphenidate is a prodrug of dexmethylphenidate that is indicated in combination with dexmethylphenidate for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged six years and older.
Associated Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/08/21 | Phase 4 | Completed | |||
2023/02/09 | Phase 4 | Active, not recruiting | |||
2023/01/17 | Phase 4 | Completed | |||
2022/12/30 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||