InhaleRx Ltd. announced that it has had a constructive pre-Investigational New Drug (`pre-IND') application meeting with the U.S. Food and Drug
Administration (`FDA') and received valuable guidance in relation to the development of its unique drug device combination product, IRX616a.
IRX616a is InhaleRx's lead cannabidiol (`CBD') formulation and drug device (Pressurised Metered Dose Inhaler, pMDI) product being developed for the treatment of Panic Disorder. InhaleRx submitted a pre-IND meeting package to the FDA for review ahead of its formal meeting in October, 2022. This package included
a description of the delivery mechanism, intended dosing regime, an overview of the proposed clinical development plan and specific questions regarding the regulatory requirements for opening an Investigational New Drug (`IND') application. Achieving an open IND ensures that the clinical trial design meets the FDA's strict data requirements necessary to obtain a New Drug Approval (`NDA'). An NDA is required in order to market the product with therapeutic claims in the U.S. and forms a strong basis for registering the drug-device combination in other jurisdictions, including in Australia via the Therapeutic Goods Administration (TGA). The FDA provided guidance on the data requirements for opening an IND for IRX616a, particularly related to the intricacies of developing an inhaled drug device combination product. The InhaleRx team was delighted to validate the regulatory pathway and the meeting with the FDA enabled the Company to make some important decisions prior to the execution phase of the trial which is scheduled to commence in April 2022. Most notably, InhaleRx has decided, based on FDA's feedback, to extend the study period of its proof of concept clinical trial in panic disorder patients from 4 weeks to 12 weeks.
The FDA guidance has also been very helpful in assisting InhaleRx further refine the scope for nonclinical toxicological studies of IRX616a in order to achieve an open IND and ultimately an NDA. In a formal written response to InhaleRx's meeting package, the FDA provided valuable, multidisciplinary feedback on the proposed clinical development pathway for IRX616a and acknowledged that treatment of anxiety is an area where there is widespread unmet medical need that has been compounded globally due to Covid-19 pandemic.