Small Pharma Inc. (TSXV:DMT) is prepping a Phase 2b clinical study to test the use of its lead candidate, SPL026, an N, N-dimethyltryptamine (DMT) in treating major depressive disorder (MDD).
DMT is present in Ayahuasca, a South American psychedelic brew.
The company has announced that it has had positive discussions with FDA regarding the planned trial.
“Importantly, the FDA’s feedback facilitates a path forward to prepare for the inclusion of U.S. sites in our Phase 2b clinical trial, which we anticipate will also be conducted across sites in Europe and the UK,” said Dr. Carol Routledge, chief medical and scientific officer of Small Pharma. “We believe that Small Pharma is conducting the first clinical trials of a DMT-assisted therapy for patients with MDD, with the potential to provide a much-needed alternative treatment for patients suffering from this debilitating condition.”
The company Small Pharma chose its name as a reaction to the phrase…