Aspire Biopharma (ASBP) said Thursday its contract manufacturer Glatt Air Techniques has produced the first clinical batch of pharmaceutical-grade oral mucosal form of aspirin with Aspire's formulation ahead of a bioavailability study expected to begin in April.
The company said it is developing a high-dose sublingual aspirin in granular or powder form to allow fast absorption for cardiology emergencies and pain management.
Aspire said it aims to complete chemistry, manufacturing and controls information for the product to support its submission to the US Food and Drug Administration. An initial meeting with the FDA is expected to be held in the second quarter, the company said.
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