$INSY Epinephrine
As a needle-free delivery method, INSYS’ epinephrine nasal spray represents a potential alternative to intramuscular injection. As reported in June 2018, the proof-of-concept study for the company’s epinephrine nasal spray product candidate showed that the drug as formulated was readily absorbed through the nasal mucosa. Subsequently, the FDA granted Fast Track designation for this investigational product in August of 2018 and provided specific guidance for clinical development and filing requirements at the end-of-Phase 2 meeting in August.
Given clinical and regulatory progress to date, INSYS believes the epinephrine NDA remains on track for filing during the fourth quarter of 2019, pending successful completion of a confirmatory PK study and no additional clinical studies requested by the FDA. The confirmatory PK study will follow completion of the now fully enrolled 48-patient dose-finding study that is expected to report results in March. Considering the Fast Track designation, INSYS plans to meet again with the FDA early in the second quarter to confirm the design of the subsequent clinical development program.
Also of note, data from the product candidate’s clinical development program will be presented at the American Academy of Allergy, Asthma and Immunology 2019 annual meeting in late February 2019. The abstract, titled “A Phase 1, Single-Dose, Open-Label, 5-Treatment, Crossover, Pharmacokinetic Study of Comparative Bioavailability of Epinephrine Nasal Spray and EpiPen® in Healthy Adults with Seasonal Allergies,” has been accepted as a poster presentation.
Nothing I say, post, or do should ever be considered financial advice. I may be holding a long, short or no position. I am NOT or NEVER have I been compensated to post on here or anywhere and all my posts are for entertainment purposes only.
