Neurotech launches Authorised Prescriber program for its neurodevelopmental disorders therapy

• Neurotech starts an authorised prescriber program for NTI164 in neurodevelopmental conditions
• The program provides controlled, specialist-led access for eligible patients in Australia, addressing strong patient and family demand
• It will generate real-world data to support regulatory registration and position NTI164 within evolving NDIS policy environment

Special Report: Neurotech International has started an Authorised Prescriber (AP) program for its therapy NTI164 across a range of neurodevelopmental conditions for paediatric patients in Australia.

Neurotech International (ASX:NTI) said the program would be managed by leading paediatric neurologist Professor Michael Fahey, head of the paediatric neurology unit at Monash Medical Centre, ensuring strong clinical oversight and structured implementation nationally.

The clinical-stage biopharmaceutical company, which is focused on paediatric neurological disorders, said the initiative follows increasing demand from patients and their families seeking access to NTI164, with limited capacity available within the company’s current clinical trials.

The AP program provides an immediate, controlled pathway for eligible patients to access NTI164 under specialist supervision while maintaining the highest standards of patient care.

Access to real-world clinical data

NTI164 is a full-spectrum cannabis extract containing cannabinoids like CBDA, CBC and CBN. However, it only contains 0.08% THC, meaning it’s non-intoxicating and suitable for children.

A central objective of the program is the generation of real-world clinical data on NTI164, which will complement the company’s ongoing and planned clinical and registration trials.

Neurotech said the data would provide further evidence of NTI164’s safety and efficacy across a broader patient population and strengthen Neurotech’s regulatory submissions, advocacy efforts, and partnering discussions.

Importantly, the AP program establishes early adoption and market presence for NTI164 ahead of pivotal clinical trials and potential registration.

The AP program has been designed to ensure patient access while being cost-neutral to the company with pricing set at a level that covers the cost of supply in addition to a modest margin.

Neurotech said the pricing structure allowed the program to fund itself while generating valuable real-world data, without being a material revenue driver for the company.

Move follows changes to NDIS with ‘strong demand’

The launch of Neurotech’s AP program comes following recently announced changes to the NDIS.

The changes will see children with mild to moderate autism spectrum disorder (ASD) diverted off the NDIS and into a newly established program by mid-2027.

Neurotech’s AP-driven real-world dataset is intended to position NTI164 appropriately within this new landscape, supporting future regulatory and commercial decision-making.

CEO and managing director Dr Anthony Filippis said launch of the Authorised Prescriber program for NTI164 marks an important step forward in its commercial access strategy.

“The program reflects the strong demand we are seeing from patients and their families and enables controlled, specialist-led access to NTI164 ahead of pivotal clinical trials and potential registration.

“Importantly, it also generates valuable data that will strengthen our submissions to regulatory agencies and aid our discussions with potential partners.

“We remain focused on putting patients and their families at the centre of everything we do, and this program provides a scalable pathway to deliver NTI164 to those who need it most.”

Fahey, who is also principal investigator of Neurotech’s ASD HARMONY phase II/III clinical trial, said he was pleased to support the launch of the authorised prescriber program for NTI164.

“This initiative represents an important opportunity to provide controlled access to a therapy that has shown encouraging potential in children with significant neurological conditions,” he said.

“For many families, there are very limited treatment options available, and the ability to access NTI164 through the AP pathway ensures that more patients can receive care under specialist supervision.”

This article was developed in collaboration with Neurotech International, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.