Grünenthal has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to their investigational medicine, resiniferatoxin (RTX), for the treatment of pain associated with knee osteoarthritis. RTX is a non-opioid therapy currently undergoing Phase III development, and early clinical data has shown significant pain relief and a favorable safety profile.
The Breakthrough Therapy Designation is a process by the FDA that aims to expedite the development and review of investigational medicines for severe conditions, especially when there is preliminary evidence suggesting substantial improvement over existing therapies. Grünenthal's Phase III program for RTX involves over 1800 patients with knee osteoarthritis who have not found adequate pain relief from other nonsurgical treatment options. The program includes trials conducted across different regions, with the goal of obtaining marketing approval in the European Union, the United States, Japan, and other countries worldwide.
Resiniferatoxin is a potent TRPV1 agonist, targeting one of the most common and severe symptoms of knee osteoarthritis. It has the potential to provide long-lasting pain relief and improve joint function while maintaining a favorable safety profile. Grünenthal plans to submit a Marketing Authorization Application in 2025, aiming for potential market entry in 2025/2026.
The Breakthrough Therapy Designation for RTX reflects the FDA's recognition of the urgent need for additional treatment options for patients suffering from knee osteoarthritis. Grünenthal is hopeful that this designation will accelerate the availability of this non-opioid therapy and provide relief to patients eagerly awaiting new treatment possibilities.