Otitopic’s proprietary formulation, OTI-0726, contains nanoparticles engineered to produce aerodynamic profiles that result in maximum deep lung delivery. The Aerodynamic profile is a result of the interaction between the inhaler and the formulation’s properties such as particle size and density. Otitopic has evaluated countless formulations and devices to ensure that patients will receive an optimal therapy for management of suspected MI. The current formulation has undergone design of experiment (DoE) studies to prepare for validation of the commercial manufacturing process. Most analytical methods have passed Phase III validation to support sale and marketing of OTI-0726 in the U.S. Otitopic has been issued multiple patents and is the only company that can market orally inhaled dry powder aspirin worldwide.
The interaction between our capsule based dry powder inhaler and proprietary formulation, OTI-0726, creates an ideal aerodynamic profile that allows for deep lung delivery of the active ingredient. The OTI-0726 dry powder inhalation device is easy to use and and is expected to be delivered into the bloodstream in less than two minutes.
The OTI-0726 is a 505(b)(2) project. FDA has agreed that a fast-paced clinical plan would be sufficient to bring the drug to market. Otitopic is currently preparing for a dose range study expected to start in Q3 2018. The pivotal PK/PD study to establish bioequivalence is expected to immediately follow the dose range study.