Antares To Start Testing ATRS-1902 With Injector Technology In Patients With Adrenal Crisis

The FDA has accepted Antares Pharma Inc's ATRS Investigational New Drug Application (IND) for ATRS-1902 for adrenal crisis rescue.
The active IND enables Antares to initiate a Phase 1 study for ATRS-1902 for acute adrenal insufficiency, known as an adrenal crisis, in adults and adolescents.
Adrenal crisis is a potentially fatal condition associated mainly with an acute deficiency of cortisol, which is a hormone produced and released by the adrenal gland. It commonly occurs in patients with long-term adrenal insufficiency.
The IND application includes a protocol for an initial study to compare the pharmacokinetic (PK) profile of the Company's formulated hydrocortisone versus Solu-Cortef, expected to initiate in 2H 2021.
A second study will then be conducted utilizing Antares' auto-injector technology.
The company expects to file a marketing application to the FDA by the end of 2022.
Price Action: ATRS shares are down 1.04% at $4.23 during the market session on the last check Thursday.
Related content: Benzinga's Full FDA Calendar.