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ORADUR-Methylphenidate · 1 trial · 1 indication
Change from baseline of Swanson, Nolan, and Pelham-IV (SNAP-IV) teacher form scores
| Arm | Type | Description |
|---|---|---|
| ORADUR®-Methylphenidate | EXPERIMENTAL | ORADUR®-Methylphenidate oral capsule will be administered once daily in the morning for 24 months. |
| Name | Type | Description |
|---|---|---|
| ORADUR®-Methylphenidate | DRUG | ORADUR®-Methylphenidate is available in three dosage forms, 22 mg, 33 mg or 44 mg. Subjects will continue to receive ORADUR®-Methylphenidate at the previously determined optimal dose for 24 months. |
Main Inclusion Criteria: 1. Subjects previously enrolled in OP-2PN012-301 study and completed 4-week study treatment 2. Both subjects and parents/guardians have provided their signed and dated informed consent form for the study Main Exclusion Criteria: 1. Subjects who experienced unmanageable ad...
ORADUR-Methylphenidate is an investigational small molecule developed by DURECT Corporation for Attention Deficit Hyperactivity Disorder. It uses DURECT's ORADUR sustained-release technology to deliver methylphenidate, a central nervous system stimulant, over an extended period. It is in Phase 3 clinical development and has not been approved by the FDA.
ORADUR-Methylphenidate is being developed to treat Attention Deficit Hyperactivity Disorder in children and adolescents. The Phase 3 trial enrolled patients aged 6 years and older with ADHD. The goal is to provide sustained symptom control with a long-acting formulation. It is investigational and not yet approved for any indication.
ORADUR-Methylphenidate targets the dopamine transporter SLC6A3 and the norepinephrine transporter SLC6A2. It acts as an inhibitor of these transporters, which increases dopamine and norepinephrine signaling in the brain. This mechanism is consistent with its active ingredient, methylphenidate, a stimulant used in ADHD treatment.
ORADUR-Methylphenidate is being developed by DURECT Corporation, which trades on the Nasdaq under the ticker DRRX. DURECT is a biopharmaceutical company focused on developing therapeutics based on its proprietary drug delivery technologies, including the ORADUR sustained-release platform.
ORADUR-Methylphenidate is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 trial, NCT02704390, was completed and evaluated long-term safety and efficacy in children and adolescents with ADHD.
ORADUR-Methylphenidate has been studied in one completed Phase 3 trial, NCT02704390, titled "Evaluate Long-term Safety and Efficacy of ORADUR-Methylphenidate in Children and Adolescents With ADHD." The trial enrolled 64 participants in Taiwan and was an uncontrolled, open-label study. No active trials are currently listed.
Yes, ORADUR-Methylphenidate and ORADUR®-Methylphenidate refer to the same investigational drug candidate. The registered trademark symbol is sometimes included in the name. Both names are used by DURECT Corporation for its sustained-release methylphenidate product in development for ADHD.