Aspire Biopharma, Microsize Partner to Develop Sublingual Alprazolam Powder for Mid-2026 Trial
Aspire Biopharma has engaged CDMO Microsize to develop the first sublingual alprazolam powder aiming for rapid-onset anxiety relief. The patent-pending formulation targets a Phase 1 trial in mid-2026 after formulations and stability studies with Pace, addressing a 15.8 million prescription market.
1. Strategic Partnership with Microsize
Aspire Biopharma has formed a strategic collaboration with Microsize, a leading CDMO specializing in particle size engineering, to develop a novel sublingual powder formulation of alprazolam, the API in Xanax®.
2. Advantages of Sublingual Delivery
The sublingual formulation is designed to bypass the gastrointestinal tract and liver, aiming to reduce onset time below the typical 25 minutes of oral tablets and deliver more predictable blood levels.
3. Clinical Trial and Development Timeline
Following initial formulation and batch manufacturing work with Pace, Aspire plans to initiate a Phase 1 clinical trial of the patent-pending powder in mid-2026 to assess safety and rapid-onset efficacy.
4. Market Opportunity and Prescription Volume
Alprazolam ranked 37th in US prescriptions in 2023 with 15.8 million scripts; the global alprazolam powder market is projected to reach $55.84 billion by 2032, driven by demand for enhanced delivery systems.