Australian inhaled cannabis developer InhaleRx (formerly Lifespot Health) announced the initiation of a Phase 1 SAD study of the company’s IRX211 inhaled dronabinol, a synthetic THC. According to the company, IRX211 was formulated by “a specialized inhalation expert group based in the UK,” and the clinical trial batch was manufactured by Ab Initio Pharma. InhaleRx is developing the metered dose inhaler for the treatment of breakthrough pain.
According to InhaleRx, the FDA “confirmed a range of matters relating to the regulatory pathway for the development and registration of IRX211 in the United States” during the company’s pre-IND meeting with the agency.
InhaleRx CEO Darryl Davies commented, “InhaleRx is delighted to announce that it has delivered as planned on the Phase 1 clinical trial milestone of having the first trial participant dosed in our IRX211 program. This is a significant milestone for the company and we are on track to complete four cohorts over the coming months. There is an increasing amount of data available that shows promising results for the use of THC for pain management. The unique design of this device-drug combination is expected to provide patients with rapid symptom management.”
Read the InhaleRx press release.
