Arynta FDA Approval History
Last updated by Judith Stewart, BPharm on July 1, 2025.
FDA Approved: Yes (First approved June 16, 2025)
Brand name: Arynta
Generic name: lisdexamfetamine dimesylate
Dosage form: Oral Solution
Company: Azurity Pharmaceuticals, Inc.
Treatment for: ADHD, Binge Eating Disorder
Arynta (lisdexamfetamine dimesylate) is an oral solution formulation of the approved central nervous system (CNS) stimulant lisdexamfetamine for use in the treatment of ADHD and binge eating disorder.
- Arynta is indicated for the treatment of:
- Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
- Moderate to severe binge eating disorder (BED) in adults. - Lisdexamfetamine dimesylate was first approved in 2007 under the brand name Vyvanse. Vyvanse and its generics are available in oral capsule and oral chewable tablet dosage forms. Arynta is the first approved oral solution formulation of lisdexamfetamine dimesylate, providing benefit to patients who have difficulty swallowing solid dosage forms, or who have a preference for using a liquid dosage form.
- Arynta is administered orally, once daily in the morning.
- Arynta carries a Boxed Warning for abuse, misuse, and addiction. Warnings and precautions associated with Arynta include risks to patients with serious cardiac disease; increased blood pressure and heart rate, psychiatric adverse reactions, long-term suppression of growth in pediatric patients, peripheral vasculopathy (including Raynaud's phenomenon), increased risk of serotonin syndrome when co-administered with serotonergic agents, motor and verbal tics, and worsening of Tourette's Syndrome.
- Common adverse reactions (incidence ≥5% and at a rate at least twice placebo)
- in pediatric patients ages 6 to 17 years, and/or adults with ADHD include anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting.
- in adults with BED include dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety.
Development timeline for Arynta
| Date | Article |
|---|---|
| Jun 16, 2025 | Approval FDA Approves Arynta (lisdexamfetamine) Oral Solution for ADHD and Binge Eating Disorder |
Further information
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