Nasus Pharma announced that it has initiated a Phase 2 study of the company’s NS002 epinephrine nasal powder, which the company is developing for the treatment of anaphylaxis. The open-label PK trial is expected to enroll 50 otherwise healthy adults who have allergic rhinitis and will compare NS002 to EpiPen injected epinephrine, with interim results expected in early 2026.
The company has previously reported results from 2 prior PK studies of NS002 (FMXIN002), a Phase 1 trial in 2021 and a second study in 2023. According to Nasus, the new study “is designed to address regulatory approval considerations by comparing bioavailability and pharmacokinetics of NS002 against EpiPen.”
NS002 is delivered via Aptar Pharma‘s Unidose nasal powder delivery device, and the company recently announced a deal with Aptar for use of that device through to potential commercialization.
Nasus CEO Dan Teleman commented, “The dosing of the first participant in our Phase 2 study marks a significant milestone for our NS002 program and for patients with severe allergies who need more user-friendly treatment options to manage life-threatening anaphylaxis. We are moving forward at full speed, executing the NS002 development program as planned, and positioning the company for its next stage of growth. For millions suffering from severe allergies, the fear of needles and the inconvenience of carrying cumbersome autoinjectors leads to poor compliance and potentially life-threatening outcomes in anaphylaxis management.”
Read the Naus Pharma press release
