FDA Grants Fast Track Designation to Non-Opioid Treatment for Osteoarthritis Knee Pain
FDA fast tracks Sun Pharma and Moebius Medical’s MM-II treatment for osteoarthritis knee pain, with Phase III clinical trials planned to expedite a potential approval.
Image credit: crevis | stock.adobe.com
The FDA has granted Fast Track designation to Sun Pharma and Moebius Medical’s MM-II treatment for osteoarthritis (OA) knee pain, with Phase III clinical trials planned to expedite a potential approval. The non-opioid product uses proprietary suspension of liposomes to provide relief for joint pain in the treatment of osteoarthritis (OA).
“As we enter Phase III development, we are very encouraged by the FDA’s decision to grant Fast Track designation to MM-II and recognize its potential to fill an unmet medical need for patients suffering from Osteoarthritis,” Marek Honczarenko, MD, PHD, senior vice president, head of Global Development for Sun Pharma, said in a press release.1
The novel, non-opioid MM-II uses a proprietary suspension of large, empty, multilamellar liposomes intended to lower friction on the joint, thereby providing relief for pain associated with OA. Findings from a Phase IIb clinical trial (NCT04506463)2 presented at the European Alliance of Associations for Rheumatology 2024 showed the efficacy of MM-II in patients with OA. The randomized, controlled, clinical trial demonstrated that a single intra-articular injection of 3 mL of MM-II produced favorable pain relief in comparison with a placebo for up to 26 weeks. Results from the trial show that patients achieved a greater than 50% improvement in knee pain from weeks 12 to 26 following treatment with MM-II.
"Given the limitations of many current therapies, there is an urgent need for more therapeutic treatment options for patients with painful osteoarthritis,” said Philip G. Conaghan, professor of Musculoskeletal Medicine at the University of Leeds and Director of the NIHR Leeds Biomedical Research Centre, in a press release. “Data from the 3mL dose of MM-II in this trial demonstrate MM-II's potential to offer durable and meaningful pain relief with good tolerability."3
These data supported the Fast Track designation from the FDA, which will expedite the development and review of the treatment, which may be eligible for the FDA’s accelerated approval process.
"With over 100 million people currently suffering from joint pain, there is a significant unmet need for additional OA therapies,” said Abhay Gandhi, CEO, North America Business, Sun Pharma, in a press release. “This analysis from our clinical trial is further confirmation of the potential role that MM-II will be able to play in improving painful OA treatment."3
OA is a common degenerative joint disease that particularly impacts the knee and is characterized by cartilage wear, pain, and motion limitations. There is currently no cure available for OA, as current treatments seek to relieve pain and improve joint function. The condition affects more than 100 million people worldwide and is a leading cause of disability.1
“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 IIb data, which showed MMII’s potential to provide effective and durable treatment for patients with knee pain of osteoarthritis,” said Moshe Weinstein, CEO, Moebius Medical, in a press release.1
References
1. Sun Pharma, Moebius Medical. Sun Pharma and Moebius Medical announce fast track designation granted for MM-II for the treatment of osteoarthritis knee pain. News Release. Released September 6, 2024. Accessed September 17, 2024. https://sunpharma.com/wp-content/uploads/2024/09/Press-Release-Sun-Pharma-and-Moebius-Medical-Announce-Fast-Track-Designation-Granted-for-MM-II.pdf
2. Efficacy and safety of MM-II for treatment of knee pain in subjects With symptomatic knee osteoarthritis. ClinicalTrials.gov. National Library of Medicine. August 29, 2024. Accessed September 17, 2024. https://clinicaltrials.gov/study/NCT04506463
3. Oral presentation at EULAR 2024 of data from global phase 2b clinical trial demonstrates durability of pain relief after a single injection of MM-II in patients with painful knee osteoarthritis (OA). News Release. Moebius. June 14, 2024. Accessed September 17, 2024. https://www.prnewswire.com/il/news-releases/oral-presentation-at-eular-2024-of-data-from-global-phase-2b-clinical-trial-demonstrates-durability-of-pain-relief-after-a-single-injection-of-mm-ii-in-patients-with-painful-knee-osteoarthritis-oa-302172939.html
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.
