From your perspective, how has the nasal drug delivery landscape evolved in recent years?
Over the last five years, nasal delivery jumped into the mainstream: think OTC Narcan and new overdose rescues (Opvee, RiVive), fast‑acting migraine sprays (ZAVZPRET, Trudhesa, Tosymra), seizure meds (Nayzilam, Valtoco), CNS (Spravato), endocrine/ENT (Baqsimi, Tyrvaya, Ryaltris, Xhance), plus regional intranasal COVID vaccines which was a really big win for nasal delivery. The pipeline sits around 120 to 180 active drug/delivery combinations worldwide R&D, with roughly 30 to 50 in Phase 3. Big wins are rapid onset, needle‑free use, first‑pass bypass, nose‑to‑brain potential, and mucosal IgA immunity. Active trials number in the hundreds worldwide—about 700 to 900 interventional in total, 150 to 250 recruiting, ~40 to 80 intranasal vaccine studies, and ~100 to 150 CNS‑focused. If I am not expect a 5% success rate as a conservative estimate, its still something substantial in the global drug delivery and related economy.
What are the biggest challenges teams face today when developing reliable, scalable intranasal formulations?
Human noses vary a lot, mucociliary clearance is fast, and hitting the upper‑posterior/olfactory region consistently is tough without causing irritation. Manufacturing adds combo‑product complexity, fill‑finish/sterility, extractables/leachables, dose uniformity, and dry‑powder handling headaches. Helpful tools include nasal casts, ALI human nasal epithelium (e.g., MucilAir‑N), RPMI 2650 screens, Franz diffusion with ex vivo mucosa, and CFD modeling. Preclinical (rodents, pigs, imaging) and clinical (scintigraphy, PK/PD biomarkers, human‑factors) are the workhorses, while devices are trending breath‑powered targeting, unit/bidose rescue formats, dry‑powders, and connected guidance. However, as of now, there is no globally adopted in vitro and pre-clinical model available to simulate nasal studies before reaching human trials. That’s going to change, but it will take a few years as I see it. The in vitro toolkit is getting smarter with ALI co‑cultures that include olfactory/neuronal components, nose‑to‑brain organ‑on‑chip systems, and patient‑specific CFD tied to PBPK calibrated by human imaging.
Looking ahead, what do you think “best-in-class” nasal delivery platforms will look like over the next 5–10 years, and what innovations are you most excited about?
Best‑in‑class platforms will nail precise upper‑posterior deposition, pair it with mucoadhesive or in‑situ gelling formulations, safe permeability enhancers, and thermostable dry‑powders—backed by CFD‑to‑PBPK models and early imaging. CNS via the nose is a definitive standout: working in minutes‑matter symptom control, potential BBB bypass for select molecules, and true self‑administration. But it will all depend on how fast the in vitro testing models evolve (as describe above).
What are you most looking forward to discussing or learning at the Nasal Formulation & Delivery Summit this May?
I’m excited to swap notes with global experts and clear roadblocks so nasal delivery can move faster for vaccines, gene therapies, and CNS meds (that’s my special interest looking at the vast market need!). I want to compare real‑world device targeting, dig into preservative‑free, biologic‑friendly formulations, and align on translational modeling plus practical scale‑up and regulatory paths.
Finally, could you share a one-line teaser of the key insight or takeaway you’ll be sharing during your session?
“Precision nasal delivery is the future of patient care — faster relief, better targeting, smarter devices.”
Find more about Deb Das and his session here.
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