InhaleRx extends proof-of-concept trial of panic disorder drug after FDA feedback
InhaleRx has announced a “constructive” pre-IND application meeting with the US FDA relating to its cannabinoid-based inhaler device.
Australian healthcare company InhaleRx (ASX: IRX) has received “valuable” guidance from the United States Food and Drug Administration (FDA) relating to the development of its unique drug device IRX616a.
The developer of medicinal cannabinoid drug device products described its pre-Investigational New Drug (pre-IND) application meeting held in October as “constructive”, saying the FDA provided guidance on the data requirements for opening an IND for its inhaled drug device combination product.
Based on the FDA’s feedback, InhaleRx has decided to extend the study period of its proof-of-concept clinical trial in panic disorder patients, which is due to start in April, from four weeks to 12 weeks.
The company said the guidance has also been “very helpful” in assisting InhaleRx further refine the scope for non-clinical toxicological studies of IRX616a in order to achieve an open IND, and ultimately, a New Drug Approval (NDA).
“We are delighted with the feedback from the FDA, the agency shared perspectives, recommendations, and preliminary agreement on critical aspects of our development program,” InhaleRx chief scientific officer Dr Rob Jenny said.
“The regulatory detail and guidance on how to navigate the risk of a clinical hold validated our chosen pathway as we enter the execution phase for the panic disorder trial,” he added.
CBD product to treat panic disorder
IRX616a is InhaleRx’s lead cannabidiol (CBD) formulation and pressurised metered-dose inhaler product being developed for the treatment of panic disorder.
The only conventional treatment for panic disorder is currently selective serotonin reuptake inhibitors (SSRIs) such as Zoloft or Prozac, which commonly have unwanted side effects.
In a formal written response to InhaleRx’s meeting package, the FDA acknowledged that treatment of anxiety is an area where there is widespread unmet medical need that has been compounded globally due to the COVID-19 pandemic.
InhaleRx chief executive officer Darryl Davies said there is a critical need for solutions which assist in managing anxiety in Australia, noting a national study of mental health and wellbeing conducted last year found an estimated one in five Australians aged 16-85 experienced a mental disorder in the previous 12 months.
“Cannabinoid-based therapeutics such as IRX616a may present a novel alternative to SSRI based treatments, that have fewer side effects and thus improve the quality of life for panic disorder sufferers.”
“We are very encouraged by the FDA’s pre-IND feedback and look forward to providing regular updates on the progress of our clinical trial program,” Mr Davies added.