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FDA Approves Arynta

FDA Approves Arynta (lisdexamfetamine) Oral Solution for ADHD and Binge Eating Disorder

June 16, 2025 – The U.S. Food and Drug Administration (FDA) has approved Azurity Pharmaceuticals' Arynta™ (lisdexamfetamine) oral solution for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older, and moderate to severe binge eating disorder (BED) in adults.

Arynta is the first oral solution formulation of lisdexamfetamine, providing a new treatment option for patients who have difficulty swallowing or have a preference for using a liquid dosage form.

Lisdexamfetamine is also available as oral capsules and chewable tablets under the brand name Vyvanse® and generic formulations.

Key Clinical Information

Efficacy: The effectiveness of Arynta has been established based on adequate and well-controlled studies of oral lisdexamfetamine dimesylate in treating adults and pediatric patients 6 years and older with ADHD, and adults with moderate to severe BED.

Dosing for ADHD: The recommended starting dosage is 30 mg once daily in the morning for both adults and pediatric patients 6 years and older. Dosage may be adjusted in increments of 10 mg or 20 mg at weekly intervals, up to a maximum dosage of 70 mg once daily.

Dosing for BED: The recommended starting dosage for adults is 30 mg once daily in the morning, titrated in increments of 20 mg at weekly intervals, up to a maximum dosage of 70 mg once daily. Treatment should be discontinued if binge eating does not improve.

Important Safety Information

Boxed Warning: Arynta carries a boxed warning for abuse, misuse, and addiction.

Contraindications: Arynta is contraindicated in patients with known hypersensitivity to amphetamine products or other ingredients, and in patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs.

Warnings and Precautions: Healthcare providers should monitor patients for risks including serious cardiac disease, increased blood pressure and heart rate, psychiatric adverse reactions, long-term growth suppression in pediatric patients, peripheral vasculopathy including Raynaud's phenomenon, serotonin syndrome, and motor and verbal tics or worsening of Tourette's syndrome.

Common Adverse Reactions

In ADHD patients, the most common adverse reactions (≥5% and at least twice the rate of placebo) included anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting.

In BED patients, the most common adverse reactions (≥5% and at least twice the rate of placebo) were dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety.

Product Availability

Arynta will be available as a 10 mg/mL clear colorless oral solution. Azurity Pharmaceuticals' launch plans for Arynta are currently pending.

Source: Drugs.com

Posted: June 2025

Arynta (lisdexamfetamine dimesylate) FDA Approval History

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