The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a first-of-its-kind trial to run this year to test psychedelic drugs as a treatment for major depressive disorder (MDD). The clinical trial will combine dosages of a new psilocin-based drug with specialist therapy.
The novel psilocin prodrug
MSP-1014, the drug being used in the clinical trial is anticipated to exert similar efficacy to psilocybin in improving symptoms of depression.
“This is an exciting milestone as we prepare to enter our first-in-human clinical trial with our novel psilocin prodrug… [which based on preclinical data] has the potential to be a better tolerated psychedelic therapeutic compared to psilocybin,"
Approval “for a Phase II study should provide us with a strong efficacy signal and expedite our pathway to approval for MSP-1014 as a new effective and more tolerable treatment for patients suffering from MDD,” added Mindset Pharma’s Chief Scientific Officer Araujo.
The MHRA’s regulatory decision comes after
Psychedelic medicines: are they gaining traction in
Europe ?
"We're incredibly excited to be given the green light for this [
Several other trials planned for the next year by psychedelic-assisted therapy clinical trial organisation
FDA publishes recommendations on psychedelic clinical trial design…
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