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Grunenthal's resiniferatoxin receives Breakthrough Therapy Designation from U.S. FDA

Monday, May 22, 2023

Grünenthal today announced that its investigational non-opioid 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 long-lasting pain relief and functional improvement of the affected joint, combined with a favourable safety profile.

Grünenthal is running a Phase III programme studying resiniferatoxin that will include more than 1800 patients with knee osteoarthritis who have insufficient pain relief with available nonsurgical treatment options. The programme comprises three trials across Europe, the United States, Latin America, South Africa and Japan to enable marketing approval for resiniferatoxin in the European Union, the United States, Japan, and other countries worldwide. Grünenthal aims to submit the first Marketing Authorization Application in 2025, leading to a potential market entry of resiniferatoxin in 2025/2026. Globally, over 360 million people are estimated to be affected by OA of the knee.1 The global osteoarthritis market is expected to grow to approximately $11.0 billion in 2025.2

Grünenthal holds the global rights for resiniferatoxin since the acquisition of the Swiss biotech company Mestex AG in 2021 and has since been holistically developing the asset to maximise its positive impact on patients worldwide. Since then, Grünenthal started a global Phase III programme, entered into a development cooperation with NovaQuest Capital Management and a licensing agreement with Shionogi for the Japanese market. If the outcome of the current Phase III programme is positive, Grünenthal intends to explore the potential of resiniferatoxin for the treatment of OA-related pain in other joints beyond the knee.

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