Otitopic announced that it has held discussions with the FDA regarding a pivotal PK/PD study of its Asprihale aspirin dry powder inhaler and now expects to initiate the study in the fourth quarter of 2020. Results are expected by the end of 2021, the company said. Otitopic is developing Asprihale for the treatment of myocardial infarction and has indicated that it also plans to develop the DPI for the treatment of lung cancer.
In November 2019, Otitopic announced that a Phase 1 study of Asprihale demonstrated that the inhalation powder produced antithrombotic effects at 2 minutes post dose compared to 30 minutes post dose for a 162 mg chewable aspirin tablet and maintained maximum antithrombotic effects at 24 hours post dose.
Read the Otitopic press release.
