The FDA has granted investigational new drug approval to an inhaler under development by Vectura, a British pharmaceutical company.
Vectura’s VR647 uses a smart nebulizer to deliver budesonide, a corticosteroid typically used as a prophylactic therapy for asthma in children. The Akita Jet device can deliver the drug to a target area in the lungs, reducing the dosage and therefore side effects. In addition, it can tell when the patient is not inhaling correctly and warn them.
The Phase I trial will start in the first half of 2017 in adults to inform the doses used in a Phase II trial in children planned for the second half of the year. The company expects to be filing for market approval as early as 2020.
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