Alprazolam is the active pharmaceutical ingredient (API) in Xanax, a commonly prescribed anti-anxiety medication.
Traditional oral alprazolam tablets can require 25 minutes or more to take effect, as absorption occurs through the gastric system and liver.
Aspire Biopharma’s new sublingual powder is designed to bypass the digestive tract and will deliver alprazolam directly into the bloodstream for faster and more predictable relief of anxiety disorders and panic attacks.
Microsize focuses on reducing particle sizes, micronisation, and enhancing solubility for drugs.
In addition to this development, Aspire Biopharma has partnered with Pace to handle drug-excipient compatibility, development of the formulation, batch manufacturing, and stability studies.
The company’s sublingual delivery technology offers precise and rapid delivery of drugs by directly entering the bloodstream while avoiding gastrointestinal absorption. It can be applied across multiple APIs and bioactive substances, including supplements and small-molecule therapeutics.
Aspire Biopharma interim CEO Kraig Higginson said: “Our collaboration with Microsize is a critical milestone in bringing a modern, fast-acting alternative to millions of patients suffering from anxiety.
“Microsize’s unparalleled expertise in particle engineering, together with the support of Pace, a leading testing and analytical lab, will allow us to optimise our sublingual powder, accelerating our journey toward a Phase I clinical trial planned for mid-2026. We are aiming to be the first alprazolam sublingual product on the market.”
Microsize operates from 100,000ft² of US Food and Drug Administration (FDA)-inspected US-based current good manufacturing practice (cGMP) facilities.