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 “Big Pharma.” Founded in 2015, the company has a pipeline focused on DMT and a ketamine metabolite.
Scientific interest in DMT, currently a Schedule I controlled substance in the U.S., has grown recently as drug developers have explored the potential of psychedelics to treat depression, post-traumatic stress disorder and other conditions.
Neuropharmacology published an article in July found DMT could be a potential adjuvant pharmacological therapy to manage acute cerebral ischemia.
In October, the Journal of Psychopharmacology published an article concluding that the drug has “potential beneficial long-term effects on mental health and well-being.” The paper also reasoned that, while further “exploration is warranted,” so are “precautions” to limit the potential of abuse and negative drug-drug interactions.
In 2019, Psychopharmacology found that DMT can lead to “sustained enhancement of satisfaction with life, mindfulness-related capacities, and a decrement of psychopathological symptoms.”
Filed Under: Neurological Disease, Psychiatric/psychotropic drugs
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