Sun Pharma and Moebius Medical gain fast track designation for MM-II for the treatment of Osteoarthritis Knee Pain
MM-II is a novel non-opioid product that uses a proprietary suspension of large, empty, multilamellar liposomes which are intended to reduce friction and wear on the joint and thus relieve joint pain
Sun Pharmaceutical Industries (and its subsidiaries or associate companies) and Israel-based Moebius Medical announced that the US Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to MM-II (Large Liposomes of DPPC and DMPC) for the treatment of osteoarthritis knee pain. Planning for confirmatory Phase 3 clinical trials for MM- II is underway.
Among other benefits, companies whose investigational products are granted FTD are eligible for more frequent interactions with the FDA during clinical development and potentially accelerated approval and/or priority review.
MM-II is a novel non-opioid product that uses a proprietary suspension of large, empty, multilamellar liposomes which are intended to reduce friction and wear on the joint and thus relieve joint pain. Data from a randomised, controlled, Phase 2b study showed that a single intra-articular injection of 3mL of MM-II provided greater pain relief than a placebo for up to 26 weeks and were recently presented at EULAR 2024. 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.
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