ARS Pharmaceuticals has announced results from the EPI-04 clinical study demonstrating that the company’s ARS-1 intranasal epinephrine spray has a pharmacokinetic profile that is similar to intramuscular epinephrine. ARS is developing ARS-1 for the treatment of anaphylaxis, and ARS-1 received Fast Track Designation for that indication earlier this year.
The EPI-04 study enrolled 36 seasonal allergy patients who received a 1.0 mg dose of ARS-1 without or without induced allergy conditions or an injection of 0.3 mg of epinephrine intramuscularly or subcutaneously or a 0.5 intramuscular injection. The study showed similar PK profiles for the 1.0 mg dose under non-allergy conditions and the 0.3 mg IM injection.
Under allergy conditions, absorption was slightly faster, the company said, but ,”The maximum plasma exposure observed with ARS-1 when dosed to subjects with moderate to severe congestion and edema, remained within the range obtained from doses approved in the US and EU product labeling, thus supporting the efficacy and safety of ARS-1 under rhinitis conditions.”
ARS Pharmaceuticals President and CEO Richard Lowenthal said, “The results of the EPI-04 study provide compelling evidence that ARS-1 has the potential to be a safe and effective option for the emergency treatment of life-threatening allergic reactions that addresses many of the current obstacles to use of auto-injectors. We believe these data, along with additional studies discussed with the FDA that are still ongoing, will be adequate to support approval of ARS-1 for patients over 25-30 kg weight that require emergency treatment of Type 1 allergic reactions including anaphylaxis. We are also working on our lower dose product for pediatric patients below 25-30 kg in weight that we hope to announce soon. If approved, ARS-1 would be the first-and-only intranasal epinephrine option for patients at risk for these events, providing a safe, low dose, reliable, needle-free treatment option that is easier to carry and use. We look forward to continuing the development of ARS-1 so it is available to the community as soon as possible.”
Read the ARS Pharmaceuticals press release.
