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FMXIN002 is an investigational intranasal epinephrine powder spray device developed by Nasus Pharma. It is designed to be a noninvasive, needle-free, user-friendly, and reliable alternative to epinephrine auto-injectors for the emergency treatment of severe allergic reactions and anaphylaxis. The product uses Nasus Pharma's proprietary powder-based intranasal (PBI) technology and is delivered via APTAR Nasal Unidose Powder device, which features intuitive one-dose nasal drug delivery and 360° functionality. Clinical studies have shown that FMXIN002 provides faster absorption of epinephrine compared to traditional auto-injectors, particularly in the critical first 30 minutes after administration. In a Phase 2 study, 91% of subjects who received a 4 mg dose reached the clinical threshold for plasma exposure at 6 minutes post-dose compared to 51% who received epinephrine from an EpiPen. The product has also demonstrated remarkable stability, maintaining 97.5% of its epinephrine base after five years of storage at room temperature, which is significantly longer than the 12-18 month shelf life of liquid epinephrine formulations.
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