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Established efficacy and safety based on clinical evidence1,2

Supported by 6 clinical studies (adults and pediatric patients), ALKINDI SPRINKLE1,3:

  • Achieved desired clinical outcomes with increases in serum cortisol in pediatric patients
  • Bioequivalent to hydrocortisone tablet and similar bioavailability to IV hydrocortisone
  • No large declines or accelerations in growth were reported for the patients who continued in the ~2.5-year study period, and no adrenal crisis or trends were seen that might indicate over- or undertreatment

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Six clinical studies have been conducted using ALKINDI SPRINKLE, including the first and only phase 3, open-label study for primary adrenal insufficiency (AI) in neonates to children <6 years of age.1,2

Overall, ALKINDI SPRINKLE was well tolerated, with a safety profile similar to that seen for hydrocortisone tablet when used as a replacement therapy for AI. There were no serious adverse reactions to ALKINDI SPRINKLE observed in any of the 6 clinical studies conducted and no episodes of adrenal crisis observed in long-term follow-up over ~2.5 years.1

Phase 3 Study
Extension Study
Bioequivalence Study to HC Tablet
Bioequivalence Study to HC Tablet & Injection
Fasted/Fed Bioequivalence Study
Bioequivalence Study to Method of Administration
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ANOVA=analysis of variance; AUC=area under the concentration-time curve; AUC0-inf=area under the concentration-time curve extrapolated to infinity; AUC0-t=area under the serum concentration-time curve from time 0 to time t; BMI=body mass index; BSA=body surface area; CI=confidence interval; Cmax=maximum concentration; DEX=dexamethasone; HC=hydrocortisone; IMP=investigational medicinal product; PK=pharmacokinetic; SD=standard deviation; SDS=standard deviation score; SOC=system organ class; tmax=time at which Cmax occurs.

*This study was designed as a safety study to evaluate the long-term use of ALKINDI SPRINKLE in routine clinical practice. Efficacy results were viewed as exploratory.1

References: 1. Data on file. Eton Pharmaceuticals, Inc. Deer Park, IL. 2. ALKINDI SPRINKLE. Package insert. Eton Pharmaceuticals, Inc; 2021. 3. Neumann U, Whitaker MJ, Wiegand S, et al. Absorption and tolerability of taste-masked hydrocortisone granules in neonates, infants and children under 6 years of age with adrenal insufficiency. Clin Endocrinol (Oxf). 2018;88(1):21-29. doi:10.1111/cen.13447. 4. Volovitz B, Kauschansky A, Nussinovitch M, Harel L, Varsano I. Normal diurnal variation in serum cortisol concentration in asthmatic children treated with inhaled budesonide. J Allergy Clin Immunol. 1995;96(6 pt 1):874-878. doi:10.1016/s0091-6749(95)70222-9. 5. Debono M, Ghobadi C, Rostami-Hodjegan A, et al. Modified-release hydrocortisone to provide circadian cortisol profiles. J Clin Endocrinol Metab. 2009;94(5):1548-1554. doi:10.1210/jc.2008-2380. 6. Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology—drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349(12):1157-1167. doi:10.1056/NEJMra035092. 7. Neumann U, Braune K, Whitaker MJ. A prospective study of children 0-7 years with CAH and adrenal insufficiency treated with hydrocortisone granules. J Clin Endocrinol Metab. 2020;dgaa626. doi:10.1210/clinem/dgaa626. 8. Whitaker MJ, Spielmann S, Digweed D, et al. Development and testing in healthy adults of oral hydrocortisone granules with taste masking for the treatment of neonates and infants with adrenal insufficiency. J Clin Endocrinol Metab. 2015;100(4):1681-1688. doi:10.1210/jc.2014-4060.