Sun Pharmaceutical Industries and Moebius Medical said that the United States Food and Drug Administration (USFDA) has granted Fast Track Designation (FTD) to its MM-II (large Liposomes of DPPC and DMPC) for 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.The company and Moebius Medical 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.
The FDAs Fast Track program 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.
Marek Honczarenko, MD, PHD, senior vice president, Head Global Development, Sun Pharma, said, As we enter Phase 3 development, we are very encouraged by the FDAs decision to grant Fast Track designation to MM-II and recognize its potential to fill an unmet medical need for patients suffering from Osteoarthritis.
Moshe Weinstein, CEO of 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 MMIIs potential to provide effective and durable treatment for patients with knee pain of Osteoarthritis.
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Moebius Medical is a clinical stage biotechnology company that is developing novel pain relief treatments for osteoarthritis
Sun Pharmaceuticals Industries is a leading global pharmaceutical company with specialty and generic presence and India's top pharma company.
The companys consolidated net profit jumped 40.20% to Rs 2,835.6 crore on 5.96% rise in revenue from operations to Rs 12,652.75 crore in Q1 FY25 over Q1 FY24.
The script rose 0.29% to Rs 1,825.75 on the BSE.
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