on Aspire Biopharma, Inc. (NASDAQ:PWUP)
Aspire Biopharma Advances Aspirin Product Development
Aspire Biopharma has achieved a significant milestone with completion of its first GMP clinical batch of pharmaceutical grade oral mucosal aspirin, thanks to contract manufacturer Glatt Air Techniques. The next phase includes CMC testing for FDA submission support. A bioavailability study with healthy volunteers is set for April 2025.
The company aims for FDA "fast track" approval of its high-dose sublingual aspirin, designed for cardiology emergencies and pain management. Their patent-pending technology offers rapid absorption, bypassing the gastrointestinal tract for improved treatment outcomes.
Aspire plans clinical trials in 2025 to further evaluate the product's pharmacodynamics and aims for FDA approval by year's end.
R. P.
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