Neumann U, et al. – In this present study, the absorption, palatability, and safety of Infacort, an immediate–release, granule formulation of hydrocortisone with taste masking were examined in children with adrenal insufficiency. Results revealed that Infacort was well tolerated, easy to administer in children. Moreover, it displayed good absorption, with cortisol levels at 60 minutes after administration similar to physiological cortisol levels in healthy children.

Methods

• In this study, fasted children were given a single dose of Infacort as dry granules administered directly from a capsule or spoon followed by a drink. 
• The maximum serum cortisol concentration up to 240 minutes after Infacort administration was considered as the primary endpoint.
• Palatability and adverse events (Aes) were included in the secondary endpoints.

Results

• In investigations, all children displayed an increase in cortisol above baseline after Infacort (p<0.0001), with geometric mean ± SD cortisol concentration at 60 min of 575.8 ± 299.5 nmol/L. 
• There was no failure in administration of Infacort, and 95.5% of parents/carers preferred Infacort to their child's current medication. 
• In 6 children who completed the palatability questionnaire, 80% of responses were very good or neutral and 20% were adverse.
• No serious or severe treatment–emergent AEs were observed.