Psycheceutical Bioscience dosed the first patient with its NeuroDirect topical ketamine. Credit: Pavlova Yuliia via Shutterstock.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.