FDA 'Breakthrough' status for Grünenthal's resiniferatoxin

Breakthrough Therapy designation has been granted by the US Food and Drug Administration (FDA) for family-owned German drugmaker Grünenthal’s investigational non-opioid medicine resiniferatoxin (RTX), as a treatment 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 favorable safety profile. The drug is currently undergoing clinical Phase III development.

“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 Dr Jan Adams, chief scientific officer of 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,” he noted.