ARYNTA (Lisdexamfetamine Dimesylate) Oral Solution

ARYNTA (lisdexamfetamine dimesylate) is a central nervous system stimulant supplied as a ready-to-use oral solution at 10 mg/mL. It is held under NDA 219847 by Azurity Pharmaceuticals, Inc., approved in June 2025 under the 505(b)(2) pathway.

NDA 219847 (Arynta [lisdexamfetamine dimesylate] oral solution) was submitted and approved under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The sponsor is Azurity Pharmaceuticals, Inc. The application was approved on June 16, 2025 as an oral solution, 10 mg/mL. Arynta is a central nervous system stimulant indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older, and for the treatment of moderate to severe binge eating disorder (BED) in adults.

Lisdexamfetamine dimesylate has been the subject of prior NDAs for the same active ingredient. NDA 021977 (Vyvanse, capsules) was approved on February 23, 2007 for the treatment of ADHD, with subsequent approvals expanding the population and adding moderate-to-severe BED in adults. NDA 208510 (lisdexamfetamine dimesylate, chewable tablets) was approved in 2017 for the treatment of ADHD in patients 6 years and older and for moderate-to-severe BED in adults. The current NDA 219847 differs from these prior applications in dosage form, providing lisdexamfetamine dimesylate as a 10 mg/mL oral solution rather than as capsules or chewable tablets, while retaining the oral route of administration and the previously approved ADHD and BED indications.

Per the prescribing information and FDA review, the current NDA 219847 was supported by new pharmacokinetic bridging data rather than new efficacy trials. A bioavailability/bioequivalence study (Study 2794) compared the pharmacokinetics of the lisdexamfetamine oral solution (test) to Vyvanse capsules (reference) in healthy adults, with dextroamphetamine exposure assessed under fed and fasted conditions to establish a bridge to the reference product. No new efficacy studies were conducted; the application relies on FDA's prior findings of safety and effectiveness for the previously approved lisdexamfetamine dimesylate products for the ADHD and BED indications.

ARYNTA is indicated for the following:

• Treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older.
• Treatment of moderate to severe binge eating disorder (BED) in adults.

ARYNTA is supplied as a clear, colorless oral solution containing lisdexamfetamine dimesylate 10 mg/mL (equivalent to 5.8 mg lisdexamfetamine per mL).

Per mL: Lisdexamfetamine dimesylate 10 mg (equivalent to 5.8 mg lisdexamfetamine)

Dibasic sodium phosphate dihydrate, methylparaben sodium, monobasic sodium phosphate dihydrate, propylparaben sodium, propylene glycol, saccharin sodium, hydrochloric acid, sodium hydroxide, and purified water.

ARYNTA is administered orally once daily in the morning, with or without food. Afternoon doses should be avoided due to the potential for insomnia. The provided oral dosing syringe and bottle adapter should be used exclusively; the adapter should remain in place throughout bottle use, and any remaining product should be discarded 30 days after first opening.

ADHD – Adults and Pediatric Patients (≥6 Years)

The recommended starting dose is 30 mg once daily in the morning. The dose may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals. The maximum recommended dose is 70 mg once daily.

Binge Eating Disorder – Adults

Begin with 30 mg once daily, then titrate in 20 mg increments at approximately weekly intervals to a target dose of 50 mg to 70 mg once daily. The maximum recommended dose is 70 mg once daily. If binge eating does not improve, discontinuation should be considered.

Renal Impairment

In patients with severe renal impairment (GFR 15 to <30 mL/min/1.73 m²), the maximum recommended dose is 50 mg once daily. In patients with end-stage renal disease (GFR <15 mL/min/1.73 m²), the maximum recommended dose is 30 mg once daily.

ARYNTA is administered orally once daily in the morning, with or without food. Afternoon doses should be avoided due to the potential for insomnia. The provided oral dosing syringe and bottle adapter should be used exclusively; the adapter should remain in place throughout bottle use, and any remaining product should be discarded 30 days after first opening.

ARYNTA oral solution (10 mg/mL) is supplied in 100 mL PET bottles with a child-resistant closure. Each sealed bottle is co-packaged with a press-in bottle adapter and an oral dosing syringe.

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F to 86°F). Keep the container tightly closed. Discard any remaining product 30 days after first opening. The approved expiry dating period is 18 months from the date of manufacture when stored at the recommended temperature.

The content below is an abbreviated summary drawn from the full prescribing information. It is meant to give a directional overview and should not be relied upon as comprehensive. Consult the full label for complete details.

No clinically significant difference in lisdexamfetamine or dextroamphetamine exposures was observed following oral administration of ARYNTA compared with lisdexamfetamine dimesylate capsules. Under fasted conditions, peak plasma concentrations of lisdexamfetamine and dextroamphetamine were reached at approximately 1 hour and 3.5 hours post-dose, respectively. Food delayed the median dextroamphetamine Tmax from 3.5 hours to 4.5 hours, without producing clinically significant differences in overall ARYNTA pharmacokinetics.

Lisdexamfetamine is converted primarily in blood (via red blood cell hydrolysis) to dextroamphetamine and l-lysine; it is not metabolized by cytochrome P450 enzymes. Unconverted lisdexamfetamine is present at low, transient levels and is generally non-quantifiable by 8 hours post-dose. The plasma elimination half-life of lisdexamfetamine averaged less than 1 hour. The dextroamphetamine half-life was approximately 8.6 to 9.5 hours in pediatric patients (6 to 12 years) and 10 to 11.3 hours in healthy adults. Following a radiolabeled 70 mg dose, the majority of radioactivity was recovered in urine, with minimal fecal recovery.

PK characterization is based on studies conducted with the capsule and chewable tablet formulations in healthy adults, and with the capsule formulation in pediatric patients with ADHD.

Two single-dose, randomized, open-label, two-way crossover comparative bioavailability studies were submitted in support of NDA 219847: Study 2793 (fasted) and Study 2794 (fed). Both studies enrolled healthy adults and compared ARYNTA 10 mg/mL oral solution (7 mL; 70 mg dose) with Vyvanse (lisdexamfetamine dimesylate) 70 mg capsules, using dextroamphetamine pharmacokinetics as the primary measure of active moiety exposure to establish the PK bridge between the oral solution and the listed drug.

The content below is an abbreviated summary drawn from the full prescribing information. It is meant to give a directional overview and should not be relied upon as comprehensive. Consult the full label for complete details.

No efficacy studies were conducted specifically for NDA 219847. The application relied on the established body of evidence for lisdexamfetamine dimesylate capsules (Vyvanse), with an initial U.S. approval in 2007. The clinical studies described in labeling reflect this prior evidence base and were not conducted with the NDA 219847 oral solution formulation.