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

Related Content

FDA approves ANDA of 20mg generic Nitisinone capsules

Analog Pharma and Dipharma have announced that the US Food and Drug Administration (FDA) has …

FDA approves Pfizer’s RSV vaccine for older adults

Global pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has …

Bristol Myers Squibb’s NDA accepted by FDA

Global pharmaceutical company Bristol Myers Squibb (BMS) has announced that its New Drug Application (NDA) …

Latest content