DYANAVEL® XR delivers
Plasma concentration curves are similar—whether DYANAVEL® XR (amphetamine) is taken fasted or fed, chewed or swallowed1,2
Eligible patients may PAY $25
Learn more about Savings & SupportConsistent plasma concentration curves under four different conditions
Mean Plasma d- and l-Amphetamine Concentration-time Profiles
for DYANAVEL® XR Tablet and Oral Suspension1,2
Will not disrupt your patients' morning routines—DYANAVEL® XR tablet
and oral suspension can be taken with or without food, chewed or swallowed
Predictable symptom control despite patient to patient variability3,4
Drug release is not affected by food, pH of the GI tract, where released in the GI tract, or metabolism of amphetamine1,5,6
*Study Details: Following a single, 20-mg oral dose of DYANAVEL XR tablet given to 36 healthy adults in a 4-period, 4-treatment, 4-sequence crossover study, exposures (Cmax and AUC) for d- and l-amphetamine were similar to administration of an equal dose of DYANAVEL XR oral suspension. The median time to peak plasma concentration (Tmax) for d- and l-amphetamine was 5 hours after dosing. The relative bioavailability of DYANAVEL XR tablet compared with an equal dose of DYANAVEL XR oral suspension, for d- and l-amphetamine, were 105% and 106%, respectively. Exposures (Cmax and AUC) for d- and l-amphetamine for DYANAVEL XR tablet chewed were similar to those when the tablet was swallowed whole and were similar under fed and fasting conditions.1,2
AUC, area under the curve; Cmax, peak concentration; Tmax, time to maximum concentration.
References: 1. Pardo A, Kando JC, King TR, Rafla E, Herman BK. Single-dose pharmacokinetics of amphetamine extended-release tablets compared with amphetamine extended-release oral suspension. CNS Spectr. 2020;25(6):774-781. 2. Dyanavel XR [package insert]. Tris Pharma, Inc., Monmouth Junction, NJ. 3. Childress AC, Wigal SB, Brams MN, et al. Efficacy and safety of amphetamine extended-release oral suspension in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psycholpharmacol. 2018;28(5):306-313. 4. Cutler AJ, Childress AC, Pardo A, et al. Randomized, double-blind, placebo-controlled, fixed dose study to evaluate the efficacy and safety of amphetamine extended-release tablets in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2022;83(5):22m14438. 5. Powell JJ, Greenfield SM, Thompson RP. Concentrations of metals in gastric juice in health and peptic ulcer disease. Gut. 1992;33(12):1617-1620. 6. Kando JC, King TR, Pardo A. A novel, modified release drug delivery technology containing amphetamine and methylphenidate ion-exchange complexes. Poster presented at: American Psychiatric Association Annual Meeting; May 1-3, 2021.