FDA approves hydrocortisone formulation for pediatric adrenocortical insufficiency
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In September, the FDA approved an immediate-release oral granule formulation of hydrocortisone for use as replacement therapy in adrenocortical insufficiency for patients younger than 17 years, according to a company press release.
Alkindi Sprinkle (Eton Pharmaceuticals) is designed specifically for use by children, who often require smaller hydrocortisone doses than adults. To allow easier titration, the drug will be available in four dose sizes: 0.5 mg, 1 mg, 2 mg and 5 mg, according to the company. The formulation incorporates excipients to mask the bitter taste of hydrocortisone.
“The FDA approval of Alkindi Sprinkle is a breakthrough for patients and caregivers treating pediatric adrenocortical insufficiency. We are excited to offer an FDA-approved product that enables low dosing and administration of hydrocortisone to pediatric patients,” Sean Brynjelsen, CEO of Eton Pharmaceuticals, said in the press release. “We look forward to making the product available to patients in the coming months.”
Approval was based on six clinical studies, including a phase 3 trial of the drug in children from birth to age 8 years, according to the release.
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