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FNP-254 is an investigational drug-device combination product consisting of an inhaled formulation of pridopidine delivered via the proprietary Staccato technology. Developed through a collaboration between Alexza Pharmaceuticals (a Ferrer subsidiary) and Prilenia Therapeutics, FNP-254 is currently in Phase 2 clinical development for the treatment of Amyotrophic Lateral Sclerosis (ALS). The Staccato platform utilizes a hand-held inhaler that generates a high-purity drug aerosol through rapid thermal vaporization, allowing for deep lung penetration and rapid systemic absorption comparable to intravenous administration. Pridopidine, the active pharmaceutical ingredient, is a highly selective Sigma-1 receptor (S1R) agonist. By activating S1R, pridopidine aims to restore cellular homeostasis and provide neuroprotection by modulating calcium signaling, enhancing mitochondrial function, and reducing endoplasmic reticulum stress in motor neurons.
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