Sun Pharma Develops Novel Treatment Approach to Osteoarthritis

Sun Pharma and Israel-based Moebius Medical announced that the USFDA has granted fast track designation (FTD) to their novel non-opioid therapy, MM-II, designed to address osteoarthritis knee pain. This designation allows for an expedited review process, intended to accelerate the development of therapies for serious conditions where there is an unmet medical need. Companies receiving FTD benefit from more frequent interactions with the USFDA during clinical trials and may receive accelerated approval and priority review.

MM-II is preparing for Phase 3 clinical trials after promising results from a randomized, controlled Phase 2b study, where a single 3mL intra-articular injection provided greater pain relief than a placebo for up to 26 weeks. Sun Pharma and Moebius Medical plan to launch the Phase 3 clinical program and seek a CE Mark for the product in the European Union.

Osteoarthritis, the most common chronic degenerative joint disease, involves the progressive wearing down of joint cartilage. Symptoms include pain around the knee joint and limited movement, and while it is a major challenge to treat, there is currently no cure for the condition.

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of US$ 5.4 billion. Supported by 43 manufacturing facilities, they provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.