The U.S. Food and Drug Administration (FDA) has granted a tentative approval for Amphastar’s Abbreviated New Drug Application (ANDA) for an injectable vasopressin therapy to increase blood pressure in adults with vasodilatory shock. As part of the clinical syndrome of septic shock, vasodilation leads to decreasing mean arterial blood pressure and subsequent multisystem organ failure. Septic shock is a severe medical condition with a 40% mortality rate in the U.S. with clinical outcomes highly dependent on the availability and timing of treatment options. Vasopressin directly stimulates vaso receptors, V1 and V2, resulting in vasoconstriction and antidiuresis. In the clinical setting, vasopressin is commonly administered intravenously and is a mainstay treatment for septic shock. The company developing the injectable therapy, Amphastar, focuses on developing genetic and proprietary inhalation, injectable, and intranasal treatment options to target a number of life-threatening conditions.
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