Sun Pharma, Moebius Medical announce FTD for MM-II for osteoarthritis knee pain treatment

Planning for confirmatory Phase 3 clinical trials for MM- II is underway

Sun Pharma 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.
 
The FDA’s Fast Track programme is designed to facilitate the development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs in order to potentially bring important new medicines to patients earlier. 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.
 
“As we enter Phase 3 development, we are encouraged by the FDA’s decision to grant Fast Track designation to MM-II and recognise its potential to fill an unmet medical need for patients suffering from Osteoarthritis,” said Marek Honczarenko, Senior VP, Head Global Development, Sun Pharma.
 
Moshe Weinstein, CEO, Moebius Medical, added, “This Fast Track Designation, which will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II, and follows our recently released Phase 2b data, which showed MM-II’s potential to provide effective and durable treatment for patients with knee pain of Osteoarthritis.”