US FDA declines to approve ARS' emergency nasal spray for allergic reactions

U.S. health regulators declined to approve a nasal spray that would have been the first needle-free emergency treatment for allergic reactions and asked for further tests, a move that left its developer ARS Pharmaceuticals "very surprised". ARS Pharma's Neffy is to be an alternative to EpiPen and other autoinjectors like Sanofi's Auvi-Q filled with epinephrine, a life-saving drug used by people at risk of anaphylaxis and other allergic reactions. The U.S. Food and Drug Administration (FDA), in its so-called "Complete Response Letter", asked the company to complete a repeat-dose study on the treatment before a potential approval, rather than after as was mutually agreed in August, ARS Pharma said late on Tuesday.

Related Keywords

Bengaluru ,Karnataka ,India ,Texas ,United States ,Sanofi Auvi ,Jahnavi Nidumolu ,Christy Santhosh ,Maju Samuel ,James Tarbox ,Richard Lowenthal ,Dhanya Ann Thoppil ,Sriparna Roy ,Texas Tech University Health Sciences Center ,Drug Administration ,Reuters ,Advisory Committee ,Sanofi Auvi Q ,Texas Tech University Health Sciences ,Fda ,Nasal Spray ,Jrs Pharma ,Allergic Reactions ,Us Food And Drug Administration ,Ars Pharmaceuticals ,Mrs ,