Centrexion Therapeutics receives fast track designation for Morton's neuroma treatment

Centrexion Therapeutics announced that CNTX-4975 has been granted a fast track designation from the FDA for the treatment of Morton’s neuroma.

Previously granted orphan drug designation for the treatment of Morton’s neuroma pain, CNTX-4975 is a highly potent, ultrapure, synthetic form of capsaicin, called trans-capsaicin, designed to be injected directly into the site of pain to provide rapid onset analgesia and a long duration of relief, according to a company press release. The release also noted the successful completion of a phase 2b randomized, double-blind, placebo-controlled, parallel group, single-injection study in patients with Morton’s neuroma, as well as an ongoing open-label, multiple-dose extension study through Centrexion Therapeutics.

“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,” Randall M. Stevens, MD, chief medical officer for Centrexion Therapeutics, said in the release. “CNTX-4975 has the potential to become the first nonsurgical 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.”

Reference:

http://centrexion.com/wp-content/uploads/2016/11/11-15-16_Centrexion-PR.pdf