Overview

IRX-616a is an inhaled drug-device combination designed for rapid intervention during acute panic attacks. This program addresses a significant gap in panic disorder treatment where current oral medications take too long to provide relief during acute episodes.

Indication

Panic Disorder affects millions of people worldwide, with prevalence increasing by 25% since the COVID-19 pandemic, and a median onset age of 24.^[4][2] Current treatments, primarily oral medications such as SSRIs, are inadequate for managing acute panic attacks due to their slow onset of action. Existing drugs can affect sleep, sexual function, carry drug interactions, and in some cases, suicidality risk.^[5]

Market Opportunity

The anxiety and depression therapeutics market is projected to reach $13.3 billion USD by 2027.^[6][1][3] There are currently no FDA-approved drugs for treating Panic Disorder via inhalation. The regulatory pathway is well defined, with a number of on-label oral drugs already FDA approved. IRX-616a could become the first FDA-approved inhaled treatment specifically designed for panic disorder, addressing a significant unmet need.