There’s good news for the 200,000 people who are annually diagnosed with Morton’s neuroma today. The US Food and Drug Administration (FDA) has just granted Fast Track Designation to a non-opioid therapy called CNTX-4975.
Morton’s neuroma is a swollen or thickened nerve in the ball of your foot – usually between the third and fourth toes – that causes severe burning or sharp pain. Experts are not entirely sure what causes the neuroma, but look to injury, pressure or irritation that triggers a response that results in the thickening of the nerve.
The potent new therapy to treat the pain is designed to be injected directly into the site of the pain. CNTX-4975 is an ultrapure, synthetic form of capsaicin (originally derived from the chili plant), called trans-capsaicin.
National Pain Report has recently reported on the benefits of capsaicin skin patches for the treatment of peripheral neuropathy, which you can read here.
The maker of CNTX-4975, Centrexion Therapeutics, successfully completed a Phase 2b randomized, double-blind, placebo-controlled, parallel group, single-injection study in patients with Morton’s neuroma. An open-label, multiple-dose extension study is ongoing. The FDA previously granted CNTX-4975 orphan drug designation for the treatment of Morton’s neuroma pain.
“The FDA’s Fast Track designation of CNTX-4975 recognizes the need for a safe and effective treatment for the painful condition of Morton’s neuroma that controls pain, but leaves other sensations intact, and could help us expedite the development of this novel, non-opioid pain treatment,” said Randall M. Stevens, M.D., chief medical officer for Centrexion Therapeutics.
“CNTX-4975 has the potential to become the first non-surgical approach approved by the FDA to treat Morton’s neuroma. With today’s announcement of Fast Track designation and the orphan drug designation CNTX-4975 previously received, we are excited to continue building on the momentum of our CNTX-4975 program with the upcoming completion of our Phase 2 open-label, multiple-dose study and initiation of a Phase 3 trial in Morton’s neuroma,” he added.
The FDA’s Fast Track process is designed to facilitate the development and expedite the review of drugs used to treat serious conditions and fill an unmet medical need. Fast Track designation enables a company to have early and frequent communication with the FDA throughout the drug development and review process, often leading to earlier drug approval.
In addition to the ongoing open-label, multiple-dose extension trial in patients with Morton’s neuroma pain, CNTX-4975 is currently being evaluated in a Phase 2b study for the treatment of chronic moderate to severe pain from knee osteoarthritis (OA) in humans and in a double-blind trial in pet dogs with OA.