Centrexion announced that the Food and Drug Administration (FDA) has granted Fast Track designation to CNTX-4975, a novel therapy intended to treat Morton’s neuroma.
CNTX-4975 is a highly potent, ultrapure, synthetic form of injectable trans-capsaicin (originally derived from the chili plant). It is designed to be injected directly into the site of pain and works by selectively targeting the capsaicin receptor (TRPV1) to inactivate the local pain fibers transmitting signals to the brain.
There are currently no FDA approved treatments for Morton’s neuroma. A Phase 2b randomized, double-blind, placebo-controlled, parallel group, single-injection study of CNTX-4975 has already been successfully completed. An open-label, multiple dose extension study is ongoing.
“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,” said Randall M. Stevens, MD, CMO for Centrexion Therapeutics.
Morton’s neuroma is a rare pain disorder in the foot, involving the thickening of the tissues around one of the nerves leading to the toes. The current standard of care is corticosteroid injection.
For more information visit centrexion.com.