There are currently no approved therapies that effectively manage moderate to severe OA pain without significant concerns related to tolerability, safety, or addiction potential. Topical CGS-200-5 (5% capsaicin) has clinically been shown to significantly reduce OA knee pain. In a Phase 2 study, CGS-200-5 reduced pain by 50% (based on WOMAC pain score) while demonstrating good safety and tolerability. CGS-200-5 also demonstrated highly durable pain relief. Patients on average reported diminished pain through 90 days, the final time point of the Phase 2 study, following just four consecutive days of topical treatment at study start. Acknowledging the therapeutic potential of topical high-concentration capsaicin, the American College of Rheumatology recently revised its OA treatment guideline to conditionally recommend topical capsaicin for knee OA pain.
The FDA recently confirmed a Phase 2b/3 pivotal study design as well as the eligibility of CGS-200-5 for the highly efficient 505 (b) (2) regulatory approval process. We anticipate filing a New Drug Application (NDA) for the product in 2024, with the potential for market clearance as early as 2025.
A topical product that can provide safe, effective and durable pain relief for OA patients has significant commercial potential. A recently completed, independent market research study projected that peak year sales of CGS-200-5 in the U.S. in excess of $1.6 billion annually.