Montana’s Tonix Pharmaceuticals has announced the design of a new Phase 2 clinical trial of TNX-1300 for the treatment of cocaine intoxication. This new protocol has the potential to serve as a pivotal trial. TNX-1300 is a recombinant enzyme that efficiently degrades and metabolizes cocaine in cocaine users, as demonstrated in a prior Phase 2a randomized, double-blind, placebo-controlled clinical study, providing support of the use of TNX-1300 as a treatment for cocaine intoxication. The company plans to submit the new protocol to the U.S. Food and Drug Administration (FDA).
