Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine news to help you catch up and stay informed
Positive Data from Small Pharma’s New Study Combining DMT & SSRIs
We received data from a Phase Ib study from Small Pharma exploring the interaction between SSRIs and SPL026, the company’s DMT drug.
The trial looked at patients with Major Depressive Disorder and initial results are positive:
- Results suggest that SSRIs enhance the efficacy of SPL026 (DMT) versus patients not on SSRIs
- At Week 4, 92% of patients on both SSRIs and DMT were in remission from depression
- No apparent differences in the safety and tolerability
Canadian Military Veteran Receives Approval for Psilocybin Therapy
Some good news as Health Canada has granted permission for a Canadian military veteran to receive much-needed psilocybin therapy.
The Canadian Armed Forces veteran is suffering from Treatment Resistant Depression and has been authorized to receive Apex Labs’ APEX-90 macrodose psilocybin. The patient will be taking Apex’s psilocybin with assisted psychotherapy.
Numinus Announces $10 Million Equity Program
Numinus has announced a $10 million at-the-market equity offering program that allows the company to issue and sell up to $10,000,000 (CAD) of common shares. At-the-market allows companies to issue shares and raise capital from time to time, at the company’s discretion.
FDA Accepts PharmaTher’s New Drug Application for KETARX™ (Ketamine)
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The FDA has accepted the company’s Abbreviated New Drug Application (“ANDA”) for KETARX™ (racemic ketamine). The goal date for this priority original ANDA of April 29, 2024.
If all goes well, PharmaTher anticipates commercial launching of its KETARX ketamine products sometime after this April 2024 date.
TheraPsil Unveils MDMA-Assisted Psychotherapy Training Program
TheraPsil, a non-profit organization dedicated to advancing legal access to psychedelic-assisted psychotherapy in Canada, is pleased to announce its latest endeavor, which has just received Board approval: an MDMA-Assisted Psychotherapy Training Program.
“We are thrilled to unveil the expansion of our training programs … We are excited to extend our support to a wider array of trauma survivors, enhancing access to legal MDMA-Assisted Psychotherapy through Health Canada’s SAP program, and steadfastly addressing the diverse needs of the patients we serve.”
