NDAORALSOLUTION
Approved
Jun 2025
Lifecycle
Growth
Competitive Pressure
0/100
Data completeness
4/8 — Partial
ARYNTA (lisdexamfetamine dimesylate oral) by R-Pharm US is dextroamphetamine. Approved for (): attention deficit hyperactivity disorder (adhd) in adults, older () lisdexamfetamine dimesylate capsules are not indicated for weight loss. First approved in 2025.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ARYNTA is a novel oral solution formulation of lisdexamfetamine dimesylate, a prodrug of dextroamphetamine with CNS stimulant activity. It is indicated for ADHD in adults and represents a new delivery option in the amphetamine stimulant class. The exact therapeutic mechanism in ADHD remains incompletely understood but involves sympathomimetic CNS stimulation.
Growth14.1 years to LOE
Early-stage growth product with recently approved oral solution formulation likely to require field-building and payer access teams as market awareness ramps.
Mechanism of Action
dextroamphetamine. Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD and BED is not known.
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.