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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 being developed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It is a long-acting formulation of methylphenidate intended for use in children and adolescents. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
ORADUR-Methylphenidate is being developed by DURECT Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol DRRX. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for the treatment of Attention Deficit Hyperactivity Disorder in pediatric patients.
ORADUR-Methylphenidate is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied for the treatment of Attention Deficit Hyperactivity Disorder in children and adolescents, with one completed Phase 3 trial.
ORADUR-Methylphenidate has one completed clinical trial, identified by the National Clinical Trial number NCT02704390. This Phase 3 study, titled "Evaluate Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD," enrolled 64 participants in Taiwan. The trial was not randomized, double-blind, or controlled, and it included a biomarker selection component.
ORADUR-Methylphenidate is a proprietary long-acting formulation of methylphenidate, a well-known stimulant medication used to treat Attention Deficit Hyperactivity Disorder. The ORADUR technology is designed to provide extended release of the active ingredient. While it contains the same active drug, it is a distinct product under development by DURECT Corporation.