The US Food and Drug Administration (FDA) has granted Fast Track Designation to RRx-001 for the prevention/attenuation of severe oral mucositis in chemotherapy and radiation-treated head and neck cancer patients.
The FDA also accepted the company’s Investigational New Drug (IND) application to initiate a follow-on Phase IIb clinical trial, called KEVLARx, in the same head and neck cancer patient population.
RRx-001, from EpicentRx, is a direct NLRP3 inhibitor and Nrf2 upregulator with anti-inflammatory and antioxidant properties.
Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious or life-threatening conditions and fulfil an unmet medical need so that they reach approval, and patients, sooner.
In this case, the unmet medical need is severe oral mucositis (SOM), for which no treatment is currently available. SOM is not only a debilitatingly painful side effect of chemotherapy and radiation, but it is also potentially life-threatening because of concomitant infections.
The benefits of Fast Track Designation include a ‘rolling review’ of completed sections of the New Drug Application (NDA), more frequent interaction with the FDA to expedite the review process, and potential eligibility for accelerated approval and priority review.
“The Fast Track Designation is great news for EpicentRx, and it puts us one step closer to a potential treatment for this critical unmet need of oral mucositis with RRx-001,” said EpicentRx CEO, Dr Tony Reid.