Drug Enforcement Agency Grants Cybin Schedule I Manufacturing License
This week in psychedelic business news, Canadian biopharmaceutical company Cybin has been granted a Schedule I manufacturing license from the United States Drug Enforcement Agency (DEA). The license is for the company’s Boston lab, and it would allow Cybin to study, produce, analyze, and work with Schedule I controlled substances. Previously, the company had carried out its research and development work through globally licensed research organizations in the United States, Canada, and the United Kingdom, but now the company can expand its internal capabilities.
Vancouver-based drug development company Filament Health’s three botanical drug candidates will be used in a first-of-its-kind clinical trial. This trial is the first using naturally sourced psychedelic extracts to be approved by the United States Food and Drug Administration (FDA) and is also the first to evaluate the direct administration of psilocin.
Revive Therapeutics and PharmaTher Partner on Microneedle Patch Technology
Biotechnology company PharmaTher is partnering with life sciences company Revive Therapeutics on the company’s proprietary microneedle patch technology for neuropsychiatric disorders. Revive Therapeutics is focused on developing its psilocybin-based product pipeline, and the company will assess the microneedle patch, MicroDose-MN, to understand how it can support its upcoming clinical and commercial developments.
Compass Pathways Launches Phase 2 Trial of Psilocybin Therapy for Post-Traumatic Stress Disorder
In other psychedelic research news, Compass Pathways has launched a Phase 2 clinical trial to assess the efficacy of the COMP360 psilocybin therapy program for post-traumatic stress disorder (PTSD). COMP360 is a synthetic psilocybin formulation that the company is currently developing for treatment-resistant depression.
Algernon Pharmaceuticals Discovers Optimal DMT Treatment Period for Neuron Growth
Algernon Pharmaceuticals believes it has discovered the optimal treatment period to achieve neuron growth using DMT. The drug development company says its in vitro experiment showed an increase in cortical neuron outgrowth of 40% was observed in a group treated with DMT for six hours – a significant statistical difference compared with the control group. Final results from the study are expected by the end of November.
Tryp Therapeutics Seeks Approval of Phase 2a Clinical Trial for Psilocybin and Fibromyalgia
Pharmaceutical company Tryp Therapeutics has submitted an Investigational New Drug (IND) Application to the FDA to evaluate the effectiveness of is psilocybin-assisted therapy for patients with fibromyalgia. If approved, the trial will assess the company’s oral formulation of synthetic psilocybin, TRP-8802, in combination with psychotherapy.
Mydecine Patents Nanotechnology Formulations of Traditional Medicine Ingredients
Finally, in psychedelic business patent news this week, Mydecine Innovations Group has filed patents covering its formulations that utilize nanoemulsion technology. Nanoemulsion is a method of drug delivery that can overcome issues associated with conventional systems, for example, providing increased control in delivery. “These GRAS-pending nanotechnology formulations offer a significant opportunity to enhance the bioavailability of natural compounds found in traditional medicine such as reishi and cordyceps so that they can be added to an expanding variety of consumer products to achieve enhanced benefits,” said Mydecine Innovations Group Chief Science Officer Rob Roscow.
