Overview

IRX-211 is an inhaled drug-device combination product designed for the rapid treatment of Breakthrough Cancer Pain (BTcP). The program has completed Phase 1 clinical trials with no serious adverse events and is approved and ready to commence Phase 2 studies.

Indication

Breakthrough Cancer Pain affects over 1.8 million cancer patients in the United States. By 2040, the global cancer burden is projected to reach approximately 29.5 million new cases annually.^[3][4] BTcP is characterised by sudden, intense pain episodes that “break through” regular pain medication. Patients require fast-acting relief that current oral medications cannot provide quickly enough, with 20–40% of U.S. cancer patients reporting cannabis use to help treat their condition.^[2]

Market Opportunity

The cancer pain management market is projected to reach $11 billion USD by 2028.^[1][2] There is a growing demand and widening gap in the market for non-opioid therapeutic options. The regulatory pathway is well defined via PIND, with 6 medications having achieved NDA for BTcP. IRX-211’s non-opioid, rapid-onset profile addresses growing concerns about opioid use in cancer care while meeting the urgent need for fast-acting pain relief.