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Amphetamine XR-ODT
- Development stage
- Approved
- Lead developer
- Aytu BioPharma
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
**Amphetamine XR-ODT (NT-0202)** is an extended-release orally disintegrating tablet (ODT) formulation of mixed amphetamine salts in a 3:1 ratio of d-amphetamine to l-amphetamine, developed by Neos Therapeutics (now Aytu BioPharma) as a 505(b)(2) application referencing Adderall XR for the treatment of attention deficit hyperactivity disorder (ADHD). The ODT format allows administration without water, disintegrating in the mouth, and provides a pharmacokinetic profile consistent with once-daily dosing, with extended-release properties maintained under fed conditions, high-fat meals, and varying alcohol concentrations (0-40% ethanol), reducing dose-dumping risk. Phase 1 studies demonstrated bioequivalence to Adderall XR at 30 mg doses, with common adverse events including headache, nausea, and catheter site issues, but no discontinuations due to AEs.[1][3][5]
- Brand names
- Adzenys XR-ODT
02
Targets
DAT (Dopamine plasma membrane transport protein)NET (Norepinephrine Transporter)VMAT2 (Vesicular monoamine transporter 2)
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