Neurotech International (NTI) has launched an Authorised Prescriber program for NTI164 – a low-THC, broad-spectrum oral cannabinoid therapy being developed for paediatric neurological conditions such as autism.
The firm said the AP scheme would provide an “immediate” pathway for eligible patients, overseen by Monash Medical Centre’s head of paediatric neurology Professor Michael Fahey.
The firm has already shared positive pharmacokinetics results for the product, showing rapid and predictable absorption of NTI164 with negligible THC exposure, and recently appointed a renowned international doctor as its chief medical adviser.
NTI chief executive Dr Anthony Filippis said the latest milestone represented “an important step forward” as Neurotech expands access to NTI164.
“[It] 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,” he said.
Professor Fahey said the program provided an important new option for children with neurological conditions.
“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,” he said.
Neurotech said the program was designed to be cost-neutral, with pricing set to cover supply costs plus a modest margin.
Real-world data generated will complement ongoing and planned trials, providing “further evidence” of the drug’s safety and efficacy.
The launch comes as reforms to the National Disability Insurance Scheme (NDIS) are set to divert children with mild to moderate autism into a new program by 2027.
The firm said the data collected through its AP initiative would help position NTI164 in this shifting policy environment, building on its earlier plans to pursue partnerships and provisional registration in Australia.