Aspire Biopharma announces results from trial of sublingual aspirin product

Aspire Biopharma (ASBP) announced top-line data from its recent randomized, crossover bioavailability trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of Aspire’s investigational new sublingual aspirin product compared to chewed uncoated aspirin tablets in healthy adults. Pharmacokinetics is the term that describes the four stages of absorption, distribution, metabolism, and excretion of drugs. Pharmacodynamics is the study of the biochemical, physiologic, and molecular effects of drugs on the body. The Aspire sublingual aspirin product produced higher and more rapid mean plasma concentrations of acetylsalicylic acid compared to chewed aspirin tablets. Significant improvement in absorption was evident within five minutes and continued throughout the first half-hour after dosing. Higher and more rapid mean plasma concentrations imply that the drug is absorbed quickly and reaches a higher concentration in the bloodstream shortly after administration. The product was also safe and well-tolerated by patients, and no adverse events were reported. Aspire Benefits of Sublingual Aspirin Drug Delivery and Bypassing the Gut vs Standard Oral Aspirin Rapid absorption through the blood vessels directly, bypassing first-pass metabolic processes Faster onset of action Sublingual route avoids exposing the drug to the harsh acidic environment of the stomach and digestive enzymes Reduced drug-food and drug-drug interactions Lower risk of GI irritation Ease of administration and use in emergency situations Clinical trial AB-101 was a randomized crossover bioavailability study of Aspire’s investigational new sublingual aspirin product compared to chewed uncoated aspirin tablets. Six otherwise healthy 40 to 65-year-old subjects were administered 162 mg aspirin as a single dose in each of three treatment periods separated by two 14-day washout periods. Two different investigational sublingual powder and granule formulations and chewed uncoated oral aspirin tablets were studied. The primary objective of the clinical trial was to evaluate the bioavailability of ASA in plasma over eight hours after dosing.