Sun Pharma-Moebius Medical anti-osteoarthritis pain drug gets USFDA fast track status

economictimes.indiatimes.com:

Sun Pharma and Israel-based Moebius Medical on Friday said that USFDA has granted fast track designation to novel non-opioid therapy MM-II against osteoarthritis knee pain.

USFDA fast track designation allows expedited review of potential therapies to treat serious conditions and fill an unmet medical need. Among other benefits, companies whose investigational products are granted FTD are eligible for more frequent interactions with the USFDA during clinical development and potentially accelerated approval and priority review.

MM2 is currently in planning stages for phase 3 clinical trials. Data from a randomized, controlled, Phase 2b study showed that a single intra-articular injection of 3mL of MM-II provided greater pain relief than placebo for up to 26 weeks.

Sun Pharma and Moebius Medical, who have been jointly developing this product, have announced plans to initiate a Phase 3 clinical program and to seek a CE Mark for the product in the European Union.

Osteoarthritis is the most common chronic degenerative joint disease, characterized by progressive wear of joint cartilage. Clinical manifestations of osteoarthritis in the knee include pain in and around the joint and limited joint motion. Osteoarthritis is among the most challenging joint diseases to treat, and currently no cure exists.