Benzinga | Jul 22, 2021 09:59AM EDT

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

* The FDA has accepted Antares Pharma Inc's (NASDAQ: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.