ARS Pharmaceuticals announced that it has submitted a supplemental NDA for Neffy 1 mg epinephrine nasal spray for the treatment of anaphylaxis in children weighing 15 to 30 kg (33-66 lbs). The FDA recently approved a 2 mg dose of Neffy for the treatment of anaphylaxis in patients weighing 30 kg or more. At that time, the company said that it intended to submit the sNDA for the 15-30 kg weight range within months.
ARS Pharmaceuticals President and CEO Richard Lowenthal commented, “Fear of needles is a common reason children refuse treatment with autoinjectors. If approved, Neffy 1 mg will be the first needle-free epinephrine option for younger children, in addition to being the first new delivery method for this population in more than 35 years. Nearly half of all current epinephrine autoinjector prescriptions are for children, and more than half of those are for children weighing 15 to 30 kg . . . . We believe there is a clear need for innovative treatments like Neffy 1 mg.”
Read the ARS Pharmaceuticals press release.
