According to Invion Limited, the company “has received a positive response” from the FDA during a pre-IND meeting regarding its INV102 inhaled nadolol for the treatment of asthma and COPD.
Invion is developing the drug in partnership with 3M Drug Delivery Systems, and the company said that the agency has accepted both the formulation and proprietary MDI technology from 3MDDS, as well as the proposed toxicology program and plans for two Phase 1 studies.
Invion Chief Medical Officer and Executive VP of R&D Mitchell Glass commented, “We are enthusiastic about the results of our pre-IND meeting. We have confirmed and clarified the path forward for the inhaled formulation of INV102 to provide lifelong treatment of chronic airway diseases. This is a key development milestone. The FDA is aware of the recent positive interim data from Invion’s smoking cessation study of oral INV102, which provided clinical target validation for using this drug to treat the airway epithelium directly. Importantly, Invion is allowed to leverage results from ongoing studies with oral nadolol to provide safety, efficacy and exposure data that will expedite inhaled nadolol development.”
Read the Invion press release.
