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FDA Grants Fast Track Designation for ATRS-1902 for Adrenal Crisis Rescue

 Last Update: 2022-02-22
 Source: Internet
 Author: User

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Recently, Antares Pharma announced that the U.

The ATRS-1902 development program supports the use of Vai's novel proprietary auto-injector platform to deliver a liquid-stable formulation of hydrocortisone for the proposed indication: treatment of acute adrenal insufficiency (known as adrenal crisis) in adults and adolescents

Adrenal crisis, also known as acute adrenal insufficiency, is a clinical syndrome caused by acute failure of adrenal cortex function due to absolute or relative insufficient secretion of adrenal cortical hormones under the action of various reasons

Just recently, Antares Pharma announced positive results from a phase I crossover study of ATRS-1902, which met its primary endpoint: In 32 healthy adults, ATRS-1902 (100 mg) provided a synergistic effect with reference drug Solu Cortef® ( 100 mg) comparable pharmacokinetic profile

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