InhaleRx (ASX:IRX) filed its quarterly report for the three months ending late September, citing expenditures of $180,000 for drug development and regulatory advice costs for clinical trials of inhaled cannabinoids for the treatment of complex regional pain syndrome and panic disorder.
During the period, the company primarily focused on refining a regulatory pathway with the U.S. Food and Drug Administration regarding drug development, as well as establishing manufacturing partnerships for supply of drug-device combinations.
It aims to obtain New Drug Approval (NDA) from the FDA as soon as possible.
InhaleRx worked with a UK-based drug formulation specialist on the development of drugs to be delivered via pressurized metered dose inhalers (pMDIs).
He said the formulation work had provided “very promising” three-month stability data.
Contract Manufacturing Partner
During the quarter, an Australia-based contract manufacturing partner was selected to produce pMDI combination products for the panic disorder trial, a contract to be formalized in the coming weeks.
InhaleRx has also initiated a tendering process to select a local or international contract research organization (CRO) for planned clinical trials.
The process was managed by a bid selection committee comprised of independent non-executive directors from InhaleRx and a specialist UK-based CRO consultant.
It is expected that the tender will be awarded by the end of November.
InhaleRx continued to develop its Medihale vaping device during the quarter and worked with various heat (not burn) inhaler device systems to better understand the pros and cons of existing products on the market.
The company’s ‘white label’ offering continues to gain traction with interest in the Australian and New Zealand markets.
During the quarter, InhaleRx made the decision to halt sales of the Voom device and canceled its remaining inventory because it had identified proven products that may be more effective at delivering cannabinoid medications.
The company plans to provide further information on the new products it plans to release in the market during the December quarter.