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FNP-253 is an investigational drug-device combination product consisting of pridopidine delivered via the Staccato inhalation technology. Developed through a collaboration between Alexza Pharmaceuticals, Ferrer, and Prilenia Therapeutics, FNP-253 is designed for the treatment of Huntington's Disease (HD). The Staccato device is a hand-held inhaler that uses thermal vaporization to create a high-purity aerosol, allowing for rapid systemic absorption through the deep lung, bypassing first-pass metabolism. Pridopidine, the active pharmaceutical ingredient, is a highly selective agonist of the sigma-1 receptor (S1R), an endoplasmic reticulum-resident chaperone protein. Activation of S1R is associated with neuroprotective effects, including improved mitochondrial function, reduced endoplasmic reticulum stress, and enhanced BDNF secretion. FNP-253 is currently in Phase 2 clinical trials to evaluate its efficacy and safety in managing symptoms of Huntington's Disease.
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