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Also known as Focalin XR
Focalin · 2 trials · 1 indication
| Name | Type | Description |
|---|---|---|
| Focalin XR | DRUG | - |
Inclusion Criteria: * DSM-IV diagnosis of ADHD * Males and females aged 6-12 Exclusion Criteria: * Inability of understand or follow instructions * Is pregnant * Diagnosis of tic disorder * History of seizure disorder
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |
| Axsome Therapeutics, Inc. | AXSM | 3 | PHASE3 | Solriamfetol |
Focalin is used to treat attention deficit hyperactivity disorder, or ADHD. It is a small molecule therapy in the psychiatry therapeutic area. The clinical program described here studied dexmethylphenidate in children with ADHD, with trials enrolling participants aged 6 years and older in the United States.
Focalin is developed by Novartis AG, which trades under the ticker NVS. Novartis is the company associated with the clinical development program for this ADHD therapy.
Focalin is in Phase 3 development for ADHD. Two Phase 3 trials have been completed, and no trials are currently active. The completed studies together enrolled 180 participants. The program is described as randomized and double blind.
Two completed Phase 3 trials studied Focalin in children with ADHD: NCT00141063 and NCT00141050. Both were titled Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD, each enrolled 90 participants, and both were conducted in the United States with participants aged 6 years and older.
Focalin XR is an alternative name for Focalin. Both names refer to the same dexmethylphenidate-based ADHD therapy developed by Novartis AG. Readers searching for either name are looking at the same drug asset and the same clinical development program.