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Aspire Biopharma Holdings, Inc., Contract Manufacturer, Glatt Air Techniques, Inc., has Completed Its First Good Manufacturing Practice (“GMP”) Clinical Batch of Pharmaceutical Grade Oral Mucosal Fast Acting Formulation of Aspirin
Subsequent phase involves completion of chemistry, manufacturing, and controls (CMC) testing for data to support FDA submission Company expects to commence bioavailability study in April 2025 Aspire intends to request "fast track" approval on FDA ...
About this update from Aspire Biopharma Holdings, Inc.
[{"type":"text","content":"Subsequent phase involves completion of chemistry, manufacturing, and controls (CMC) testing for data to support FDA submission","length":127,"tagName":"p"},{"type":"text","content":"Company expects to commence bioavailability study in April 2025","length":63,"tagName":"p"},{"type":"text","content":"Aspire intends to request "fast track" approval on FDA application for its high dose aspirin product ","length":121,"tagName":"p"},{"type":"text","content":"HUMACAO, PR AND NEW YORK, NY / ACCESS Newswire / March 20, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) ("Aspire" or the "Company"), a developer of a multi-faceted patent pending drug delivery technology, today announced that it its contract manufacturer, Glatt Air Techniques, Inc., part of Glatt Group, a vertically integrated pharmaceutical services company with FDA- and EU-approved sites, has completed its first Good Manufacturing Practice ("GMP") Clinical Batch of its pharmaceutical-grade oral mucosal formulation of aspirin that utilizes Aspire's fast-acting formulation. Aspire's GMP extracts are set to be administered in a bioavailability study in healthy human volunteers in April 2025.","length":745,"tagName":"p"},{"type":"text","content":"Aspire's lead product candidate, high-dose sublingual aspirin, is a granular or powder formulation of a soluble, Ph neutral, fast-acting aspirin designed to address cardiology emergencies and pain management. Aspire believes the benefits of "rapid absorption" aspirin include the potential to quickly address cardiac incidents; allow high dose absorption for pain management including fast headache relief, post-surgery, cancer pain management, and general pain relief. The benefits of "rapid absorption" are to provide nearly instant treatment impact and high dose absorption. The Company's patent pending delivery system includes components specifically formulated to allow rapid sublingual absorption of drugs into the blood stream, thus by-passing the gastrointestinal tract, and potentially provide an improved treatment outcome.","length":862,"tagName":"p"},{"type":"text","content":""This marks another important milestone for Aspire," commented Kraig Higginson, Chief Executive Officer of Aspire. "We have been collaborating with Glatt Air T...