First mixed
amphetamine salts

to use triple-bead delivery for prolonged delivery through the morning, afternoon, and evening.1,2

The three bead types within Mydayis release mixed amphetamine salts (MAS) at different pH levels, enabling prolonged amphetamine delivery over time as the pH in the digestive tract changes.1,3,4

First Bead: Immediate-release Provides immediate MAS drug release in the stomach

First Bead:
Immediate-release

Provides immediate drug release in the stomach.

Second Bead: Delayed-release (DR-1) Provides a delayed release of mixed amphetamine salts at pH 5.5, predicted to occur in the proximal small intestine

Second Bead:
Delayed-release (DR-1)

Provides a delayed release of mixed amphetamine salts at pH 5.5, predicted to occur in the proximal small intestine.

Third Bead: Delayed-release (DR-2) Has two coatings; the first coating is porous which allows for a slow release of amphetamine. The second coating delays release of the medication until pH 7.0, which is predicted to occur later in the GI tract (distal small intestine)

Third Bead:
Delayed-release (DR-2)

Has two coatings; the first coating is porous which allows for a slow release of amphetamine. The second coating delays release of the medication until pH 7.0, which is predicted to occur later in the GI tract (distal small intestine).

Beads are not to scale and colored for visualization only.


EXTENDED DRUG DELIVERY

MYDAYIS reduced peak-to-trough FLUCTUATIONS VS A DOSE-AUGMENTATION STRATEGY1,4

With one capsule of Mydayis 37.5 mg, healthy adults achieved similar plasma concentrations as with a dose of MAS-ER (other) 25 mg followed by a dose of MAS-IR 12.5 mg 8 hours later.

Mean Plasma Concentration in Adults

Mean plasma concentration of MAS over time

Efficacy conclusions cannot be drawn from pharmacokinetic data.

Mydayis delivers d- and l-amphetamine salts at a 3:1 ratio; similar kinetics are seen for l-amphetamine.

MAS-ER=Mixed amphetamine salts extended release
MAS-IR=Mixed amphetamine salts immediate release

Adolescent patient data

  • Based on a study of adolescent patients aged 13-17 (n=14), a single dose of Mydayis is expected to produce about 21%-31% higher Cmax and AUC for d- and l-amphetamine, compared to the same dose of Mydayis administered to adults (aged 19 to 51 years).1
  • Comparison of the amphetamine pharmacokinetics in adolescent patients with ADHD and healthy adults indicates that body weight is the primary determinant of these apparent differences.1
References
  1. Mydayis [package insert]. Lexington, MA; Shire US Inc.
  2. Spencer TJ, Adler LA, Weisler RH, Youch SH. Triple-bead mixed amphetamine salts (Mydayis), a novel, enhanced extended-release amphetamine formulation for the treatment of adults with ADHD: a randomized, double-blind, multicenter, placebo- controlled study. J Clin Psychiatry. 2008;69(9):1437-1448.
  3. Nugent SG, Kumar D, Rampton DS, Evans DF. Intestinal luminal pH in inflammatory bowel disease: possible determinants and implications for therapy with aminosalicylates and other drugs. Gut. 2001;48(4):571-577.
  4. Ermer JC, Shojaei A, Pennick M, Anderson CS, Silverberg A, Youcha SH. Bioavailability of triple-bead mixed amphetamine salts compared with a dose-augmentation strategy of mixed amphetamine salts extended release plus mixed amphetamine salts immediate release. Curr Med Res Opin. 2007;23(5):1067-1075.