WEX Pharmaceuticals to start tetrodotoxin trial

By Elaine Rigoli

Tampa, Fla., June 12 - WEX Pharmaceuticals, Inc. has received approval for its Investigational New Drug application with the Food and Drug Administration to start a clinical trial of Tectin.

WEX said this represents a significant achievement since, for the first time, the company will perform a trial under a U.S.-IND number, and this will grant access to a major patient population base for future tetrodotoxin (TTX) development.

The trial is designed to assess the kinetics of TTX after a single subcutaneous dose to understand the fate of the drug in the body in healthy volunteers.

As the dose of TTX administered to humans is very small, no established method was sensitive enough to detect the product in biological fluids and, therefore, the kinetics of TTX were not known, the company said in a news release.

Recently, a more sensitive analytical method, which might allow the company to assay TTX in blood/plasma and/or urine human samples, has been developed, the release said.

This will allow the company to proceed with this study and obtain information about TTX kinetics, data crucial to the successful development of the product.

Vancouver, B.C.-based WEX Pharmaceuticals develops drug products to treat pain.

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