Show of hands, who loves needles… anyone?
Well for those who don’t, epinephrine delivered via nasal spray has been in development for quite some time. Here’s the update on two promising intranasal models.
ARS Pharma’s nasal spray neffy® is for the treatment of allergic reactions (type 1), including anaphylaxis for adults and children 66+ pounds. Its New Drug Application was accepted by the FDA and has been under review. In June the company announced that the FDA extended the PDUFA approval (prescription drug user fee act) date by 3 months to mid-September for discussions regarding labeling and post-marketing requirements. neffy® already received a positive benefit-risk assessment by the FDA Pulmonary-Allergy Drug Advisory Committee in May, but the Agency needs additional time for review.
You can read the full press release here.
Bryn Pharma is also developing an affordable, needle-free epinephrine nasal spray device named UTULY™, which recently completed “Phase 3 pivotal clinical trial have been accepted and will be presented as late breaking news at the American Academy of Allergy, Asthma and Immunology (AAAAI) annual meeting” in February of 2023. You will find the press release here.
Per press release in March, data was presented at the ASCPT Annual meeting “UTULY 13.2mg Intranasal Epinephrine Spray Provides Enhanced PK Profile (higher and more sustained) Compared to 0.3mg Epinephrine Autoinjector (EpiPen) in Subjects with and without Nasal Congestion.”
As of late summer, 2023, for the first time, our Medical Advisory Board members are more confident than they've been for some time, that one or both of these options will come to market in the next year, offering relief to those who hate needles.