The needle-free nasal spray, if approved, would be the first new administration method for epinephrine in young children in 35 years.
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The approval of neffy (epinephrine nasal spray) could help individuals and caregivers act sooner and feel safer treating a type 1 allergic reaction.
neffy (epinephrine nasal spray) is the first alternative to epinephrine administered by autoinjector or syringe and is comparable in efficacy to the gold standard.
PK data from a self-administration study are comparable to those seen following administration by a clinician and Tmax equal at 15 minutes.
Positive findings from a repeat dosing study of neffy under nasal allergen challenge conditions will support a potential PDUFA date of October 2, 2024, the company said.
Now FDA approved, Optinose’s Xhance is the first nonsurgical option for chronic rhinosinusitis both with and without nasal polyps.
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Dr Ebisawa details the findings he recently presented at the 2024 AAAAI annual meeting, including adverse events and next steps for the study.
AAAAI 2024. Needle phobia is just one of the barriers to not just using an epinephrine autoinjector but to carrying one at all, according to 2 sets of surveys findings.