ARS Pharma Readies Data In Response To FDA’s Rejection For Its EpiPen Alternative For Severe Allergic Reactions
Tuesday, ARS Pharmaceuticals Inc (NASDAQ:SPRY) released topline results from its clinical study comparing repeat doses of neffy (epinephrine nasal spray) to repeat doses of epinephrine intramuscular (IM) injection.
ARS Pharma intends to submit this repeat-dose NAC study data to the FDA as part of its response to the CRL early in the second quarter of 2024.
The randomized, crossover pharmacokinetic (PK) and pharmacodynamic (PD) study enrolled 43 patients.
NAC involves spraying purified antigen directly onto the nasal mucosa – a ‘worst-case’ experimental condition in contrast to real-world nasal conditions such as upper respiratory tract infections or acute allergic rhinitis from natural causes.
All patients …
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