Aspire Biopharma announces Type B pre-investigational new drug meeting with FDA

Aspire Biopharma (ASBP) announced the outcome of a Type B pre-investigational new drug meeting with the FDA. The meeting provided a regulatory roadmap for the company’s investigational new drug, acetylsalicylic acid 162 mg sublingual powder, designed for the emergency treatment of suspected acute myocardial infarction. The FDA’s written responses provide the necessary guidance to finalize the company’s clinical and regulatory development strategy. Based on FDA’s feedback, Aspire anticipates completing a currently planned multicenter crossover clinical trial and then submitting a Section 505 new drug application. The clinical trial will evaluate serum thromboxane B2 inhibition in 32 healthy volunteers, comparing OTASA against the current standard of care-two chewed 81 mg aspirin tablets.