The breakthrough non-opioid medicine, MM-II, developed by Sun Pharma and the Israeli pharmaceutical company Moebius Medical was awarded Fast Track Designation by the U.S. Food and Drug Administration (FDA) on Friday. The therapy is intended to relieve knee pain associated with osteoarthritis. This designation is important because it opens the door to a quicker review process for medications that treat serious illnesses or unmet medical needs.
The FDA grants Fast Track Designation to expedite the development and review of medicines that address grave or life-threatening illnesses and address unmet medical needs. In comparison to usual methods, this means that MM-II will benefit from more frequent interactions with the FDA during its clinical development phase, which could result in faster approval and priority review.
Phase 3 clinical trial planning is presently underway for MM-II. It has previously undergone a Phase 2b research, which was randomized and controlled and showed encouraging results. The study discovered that, in comparison to a placebo, a single 3 mL intra-articular injection of MM-II considerably reduced pain. For patients with arthritic knee discomfort, MM-II may provide long-lasting benefits, as seen by the pain alleviation that persisted for up to 26 weeks.
The most common chronic joint condition, osteoarthritis, mostly affects the knee. It is distinguished by the gradual degradation of joint cartilage, which causes discomfort, stiffness, and a restricted range of motion. Although there is currently no cure for osteoarthritis, the condition can be difficult to manage. Instead of treating the fundamental cause of cartilage degeneration, current treatments only target the symptoms.
Sun Pharma and Moebius Medical intend to apply for a CE Mark for MM-II in the European Union in addition to getting ready for Phase 3 clinical trials in the United States. A CE Mark would increase the therapy’s potential impact by enabling it to be marketed and utilized in EU nations.
Because MM-II provides a non-opioid alternative to existing medications, it represents a substantial advancement in the treatment of osteoarthritis knee pain. Although opioids are useful in treating pain, they also carry a risk of addiction and other negative effects. For this reason, non-opioid alternatives are often preferred when treating chronic pain issues.
SOURCE :
ECONOMICS TIMES
