Grünenthal receives FDA Breakthrough Therapy Designation for knee osteoarthritis drug
James Spargo | May 23, 2023 | News story | Medical Communications | Breakthrough Therapy Designation, FDA, Grunenthal, Musculo-skeletal disorder, osteoarthritis
German pharmaceutical company Grünenthal has announced that the US Food and Drug Administration (FDA) has awarded it Breakthrough Therapy Designation (BTD) for its investigational non-opioid medicine, resiniferatoxin (RTX), for the treatment of pain associated with osteoarthritis (OA) of the knee.
RTX is a highly potent Transient Receptor Potential Vanilloid 1 (TRPV1) agonist, created from the discovery of a number of receptors, including TRPV1, and their perception of temperature and touch. It is an intra-articular injection which can reversibly defunctionalise TRPV-1-expressing nociceptors.
The FDA’s decision to award the BTD was based on phase 1 and 2 data which showed significant pain relief and a positive safety profile. Grünenthal is currently running phase 3 trials across Europe, the US, Latin America, South Africa, Japan and others, including more than 1,800 patients who have insufficient pain relief from nonsurgical treatment options.
Grünenthal aims to submit a Marketing Authorisation Application in 2025, with potential market entry in 2025/2026.
Jan Adams MD, CSO at Grünenthal, commented: “Millions of patients suffering from knee OA are waiting for additional treatment options. Resiniferatoxin targets one of the most common and severe symptoms of this currently incurable disease: pain. The decision shows that the FDA considers OA a serious disease and shares our assessment of resiniferatoxin’s potential to make a positive impact. We are hopeful that the BTD will help us to bring this non-opioid therapy option more quickly to patients.”
James Spargo
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