Aspire Biopharma's Sublingual Aspirin Product Shows Promising Results in Crossover Bioavailability Trial

Aspire Biopharma Holdings' shares are trading higher after announcing positive results from its crossover bioavailability trial for its investigational sublingual aspirin product. The study showed that the new product worked faster and more effectively than standard chewed aspirin tablets in healthy adults, with no side effects reported. The company plans to review the results with the FDA to support a potential application for accelerated approval.

Aspire Biopharma Holdings' shares are trading higher following the announcement of positive results from its crossover bioavailability trial for an investigational sublingual aspirin product. The trial demonstrated that the new product achieved higher and more rapid plasma concentrations of acetylsalicylic acid compared to standard chewed aspirin tablets in healthy adults, with no reported side effects [1].

The randomized crossover bioavailability study involved six healthy subjects aged 40-65 years, who received 162mg aspirin doses across three treatment periods. The sublingual delivery system showed significant improvement in absorption within five minutes and continued throughout the first half-hour after dosing [1].

Aspire's sublingual aspirin product has the potential to revolutionize the treatment of suspected acute myocardial infarction (AMI), also known as a heart attack. The study's findings suggest that the new formulation could provide faster antiplatelet action, potentially reducing myocardial damage and improving survival rates [1]. This is particularly significant given that approximately 800,000 Americans experience AMI annually, resulting in 300,000 deaths [1].

The company plans to review the results with the FDA to support a potential application for accelerated approval. This strategic move is logical given the urgent medical need and extensive existing safety data on aspirin [1]. If successful, this could dramatically shorten the timeline to commercialization.

Aspire's sublingual aspirin product is an investigational new drug and has not been approved for marketing by the FDA or any other government regulatory authority. The company's patent-pending drug delivery technology suggests that it has established intellectual property protection, creating potential barriers to competition [1].

References:
[1] https://www.stocktitan.net/news/ASBP/aspire-biopharma-announces-positive-top-line-results-from-clinical-99lu0y7r5eu4.html