• Knee osteoarthritis is a progressive condition affecting over 360 million people worldwide and may have severe symptoms, including pain.
• Grünenthal is running a global Phase III programme to investigate the efficacy and safety of intra-articular injections of resiniferatoxin, a non-opioid therapy, in adults with pain associated with knee osteoarthritis.
• The U.S. Food and Drug Administration’s Breakthrough Therapy Designation process aims to expedite the development of investigational medicines intended to treat severe conditions and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on clinically significant endpoints.
Aachen, Germany, 22 May 2023 – Grünenthal today announced that its investigational nonopioid medicine resiniferatoxin (RTX), currently undergoing clinical Phase III development, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for pain associated with osteoarthritis (OA) of the knee. The decision is based on clinical phase I and II data indicating significant pain relief and a favourable safety profile. “Millions of patients suffering from knee osteoarthritis are waiting for additional treatment options. Resiniferatoxin targets one of the most common and severe symptoms of this currently incurable disease: pain,” says Jan Adams, M.D., Chief Scientific Officer Grünenthal. “The decision shows that the FDA considers osteoarthritis a serious disease and shares our assessment of resiniferatoxin’s potential to make a positive impact. We are hopeful that the Breakthrough Therapy Designation will help us to bring this non-opioid therapy option more quickly to patients.”
Resiniferatoxin is a highly potent Transient Receptor Potential Vanilloid 1 (TRPV1) agonist with a well-validated mechanism of action. The discovery of a number of receptors, including TRPV1, and their role in the perception of temperature and touch was awarded the 2021 Nobel Prize in Physiology or Medicine. If approved, resiniferatoxin has the potential to become a meaningful non-opioid treatment option providing....READ MORE
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• Knee osteoarthritis is a progressive condition affecting over 360 million people worldwide and may have severe symptoms, including pain. • Grünenthal is running a gl...
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