SBTX - ARS Pharmaceuticals nasal spray neffy for allergic reactions gets FDA review

• Silverback Therapeutics ( NASDAQ: SBTX ) said the U.S. Food and Drug Administration (FDA) accepted for review ARS Pharmaceuticals' application seeking approval of nasal spray neffy as emergency treatment of allergic reactions (type I) including anaphylaxis in adults and children ?30 kg (66 lbs).
• If approved, neffy (epinephrine nasal spray) would be the first non-injectable therapy available to patients with allergic reactions (type I) including anaphylaxis, the company said in press release on Friday.
• The FDA is expected to make a decision on the new drug application (NDA) by mid-2023.
• The NDA was backed by data from four studies supporting that a 2 mg intranasal dose of neffy met all clinical goals and that its pharmacokinetics were within the range of approved epinephrine injection products, the company added.
• In July, Silverback and ARS Pharma said they were merging in an all stock transaction.

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