US-based Psycheceutical Bioscience has dosed the first healthy volunteer in a Phase I trial investigating a topical administration of ketamine for the treatment of post-traumatic stress disorder (PTSD).
The trial is evaluating Psycheceutical’s patented NeuroDirect ketamine topical delivery system that is designed to target free nerve ending at the back of the neck. As such, the company believes that psychedelic medicine is delivered safely and effectively without hallucinogenic effects.
The Phase I trial will evaluate the safety, tolerability and pharmacokinetics of a single dose of NeuroDirect ketamine in 24 healthy volunteers. According to Psycheceutical, this clinical programme is the first ever to investigate the topical administration of ketamine and its use in mental health disorders.
The Phase I study builds on positive preclinical results from an observation study which showed that 80% of participants benefited from NeuroDirect ketamine. The study recruited 100 patients with no response to traditional PTSD therapies.
CEO Chad Harman said: “With our goal of a non-systemic treatment for PTSD using legal ketamine, we are attempting to pave the way for our future drug candidates to treat other mental health disorders.”
Upcoming Phase II trial
Alongside the healthy volunteer trial, Psycheceutical plans to conduct a Phase II trial with the PTSD patient population. In February 2023, the company announced that it will enrol 115 participants to test the effectiveness of NeuroDirect ketamine in improving symptoms.
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The trial was designed to be considered a pivotal clinical trial by the US Food and Drug Administration (FDA). This way, the company could directly proceed to a Phase III trial rather than an additional Phase IIb trial, resulting in time and cost savings.
However, the company did not disclose the estimated trial initiation date for the Phase II trial.
Both trials are conducted by contract research organisation (CRO) iNGENū in Australia. Psycheceutical noted that the company chose Australia due to its federal government’s Research & Development Tax Incentive Programme, which will provide the company with up to 43.5% of rebates on “eligible expenditures for research and development conducted in Australia”.
Global regulatory trends on psychedelics
Australia has made immense strides in psychedelic treatments for mental health disorders. On 1 July, Australia became the first country to allow psychiatrists to prescribe psilocybin and 3,4-Methylenedioxymethamphetamine (MDMA) for controlled clinical use.
Last month, the FDA released its first draft guidance on clinical trials investigating psychedelic drugs. In the document, the agency outlines inherent challenges in psychedelic trials and provides considerations to researchers. Industry stakeholders are welcome to provide feedback by 23 August 2023.