Aspire Biopharma, Inc. Signs Pharmaceutical Development Agreement with Glatt Air Techniques, Inc.
HUMACAO, PR, January 18, 2024 – Aspire Biopharma, Inc. (“Aspire” or the “Company”), a developer of disruptive drug delivery mechanism technologies, today announced that it has organized and solidified its timeline for its contemplated 505(b) fast track FDA Trial on its initial product Instaprin. Aspire will be meeting with Glatt Air Techniques, its development and production partner team, in preparation for its GMP batch run of Instaprin for human trial testing managed by its CRO Parexel. Further, the Company’s world-renowned FDA counsel and advisory team will be organizing an all-hands FDA 505 (b) meeting in mid-February to coincide with the production for Instaprin and the contemplated clinical trial.
Kraig Higginson, Executive Chairman, stated, “Aspire is in the last planning phase for successfully launching and navigating the 505(b) fast track approval and clinical trial processes for Instaprin targeting a significant public health need as a true therapeutic pain management tool as an alternative and/or replacement for Opioid prescribing. This powerful rapidly absorbed aspirin product has the potential to make a huge impact on heart attack and stroke and migraine sufferers.”
About Aspire Biopharma, Inc. Headquartered in Humacao, Puerto Rico, Aspire Biopharma has developed a disruptive technology through a Novel Soluble Formulation which addresses emergencies, drug efficacy, dosage management, and response time. For more information, please visit www.aspirebiolabs.com.
About Glatt Air Techniques, Inc. Based in Ramsey, New Jersey, Glatt focuses on product development and manufacturing optimization for granules used in the nutritional, food, feed, pharmaceutical and fine chemicals markets. For more information, please visit www.glatt.com.
About Parexel. One of the world’s largest clinical research organizations (CROs) providing the full range of Phase I to IV clinical development services, leveraging the breadth of its clinical, regulatory and therapeutic expertise, with a team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders and sites to design and deliver clinical trials with patients in mind, to make clinical research a care option for anyone, anywhere.
Safe Harbor Statement. Certain information set forth in this news announcement may contain forward-looking statements that involve substantial known and unknown risks and uncertainties. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of Aspire Biopharma, Inc. Such forward-looking statements are based on current expectations, estimates and projections about the Company’s industry, management beliefs and certain assumptions made by its management. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. Information concerning factors that could cause the Company’s actual results to differ materially from those contained in these forward-looking statements can be found in the Company’s Form CF and Form D, filed with the Securities and Exchange Commission. Unless required by law, the Company undertakes no obligation to update publicly any forward-looking statements, whether because of new information, future events, or otherwise to reflect future events or circumstances or reflect the occurrence of unanticipated events.