Indian pharmaceutical company Sun Pharmaceutical Industries Limited (NSE:SUNPHARMA) (BSE:524715) and Israel-based Moebius Medical Limited announced on Friday that the US Food and Drug Administration (FDA) has granted Fast Track designation to MM-II (Large Liposomes of DPPC and DMPC) for treating osteoarthritis knee pain.
Fast Track designation expedites the development and review process for therapies addressing unmet medical needs. This allows for more frequent interaction with the FDA during clinical development and potentially faster approval.
MM-II, a novel non-opioid product, is currently in Phase 2b trials with promising results. Sun Pharma and Moebius Medical are planning confirmatory Phase 3 trials.
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