Myoscience Completes Patient Enrollment in Two Knee Pain Relief Studies

Myoscience Inc. has completed enrollment in two prospective, randomized placebo-controlled studies focused on relieving knee pain. Both studies are designed to measure the efficacy of iovera, a proprietary, U.S. Food and Drug Administration-cleared treatment that freezes the peripheral nerves in the knee and blocks the transmission of pain.

The iovera treatment provides an immediate nerve block that is a non-systemic, non-narcotic solution to blocking pain for an extended period of time, company executives said. The treatment has been commercially available in the United States since March 2014.

The MYO-1070 study evaluates post-surgical pain management for patients treated prior to undergoing a total knee replacement; 150 patients were enrolled and the enrollment target was reached six weeks early. The primary endpoint is cumulative opioid consumption at six weeks post-total knee arthroplasty (TKA) surgery, comparing the iovera treatment group and the control group. The MYO-0946 study evaluates iovera as a temporary nerve block for patients with chronic knee pain due to osteoarthritis. One hundred eighty patients were enrolled. The primary endpoint hypothesis of the study is that the change in score after 30 days under iovera is superior to that of control. Both studies will be critical at establishing the iovera treatment as a non-systemic alternative for effective pain therapy. Results of the studies will be available later this year.

Dr. Antonia Chen, an orthopedic surgeon at the Rothman Institute in Philadelphia, Pa., is an investigator in MYO-1070. She claims there is significant potential for therapies like the iovera treatment. “Opioid abuse is becoming a larger problem in our society, and it may be beneficial to add non-narcotic pain therapies such as iovera to reduce pain in our total knee replacement patients,” Chen said.

The iovera system is comprised of a handheld unit, charging dock, and disposable Smart Tips, which deliver Myoscience’s patented focused cold therapy technology to treat peripheral nerves to block pain. Using the body’s natural response to cold, the iovera system can immediately relieve peripheral nerve pain — without the use of drugs or other systemic therapies, company bigwigs noted.

“The duration of effect of the iovera treatment will make it a useful adjunct for surgical applications, especially knee replacement surgery,” said Dr. Richard Berkowitz, orthopedic surgeon at the Phoenix Clinical Research Institute in Tamarac, Fla., and an investigator in MYO-1070. “Our staff have become experts on performing the treatment and it is a fast, safe and simple treatment to do in an office or hospital setting.

Based in Fremont, Calif., Myoscience is a privately held company focused on making its platform technology, focused cold therapy, the standard of care for the treatment of peripheral nerve conditions. The iovera system is cleared in the United States for the blocking of pain.