1st topical filmogen antihistaminic spray for
the treatment and prevention of Allergic Rhinitis (AR)
Nearly 15-20% world population suffers from Allergic Rhinitis. Allergy is a false reaction of the immune system to a substance. Allergens stimulate topical TH1 & TH2 cells. Cytokines (proteins) produced by TH2 cells stimulate B cells to proliferate & differentiate into IgE producing cells. IgE binds to mast cells which liberates histamine.
Upon a following exposure, the allergens bind directly to the IgE antibodies on the mast cells which instantly release histamine & other inflammatory cytokines, triggering allergic symptoms, inflammation, edema, & pain. Histamine & IgE production after an allergen attack is nearly instant.
Ideal Treatment should:
- Act topically to avoid side effects
- Stop contact between allergen & mucosa
- Block IgE proteins to stop mast cell activation
- Block histamine directly on the nasal surface
- Stop inflammation
- Act within a few seconds / minutes
Many OTC & a few Rx drugs such as corticosteroids, antihistamines, decongestants, leukotriene receptor antagonists, mast cell stabilizers, anticholinergic with multiple side effects.
Estimated market for an anti-allergic rhinitis drug:
Current US$ 9 Bn to US$ 14 Bn in 2022.
Allergic rhinitis is a complex immunological disease involving allergens & 3 key proteins: IgE + histamine + Inflammatory proteins. The only way to treat such a disease effectively is to stop allergen exposure or to block all the 3 key proteins simultaneously. Unfortunately, multiple protease inhibitor drugs are not yet discovered.
VITROBIO‘s Completely NEW Therapeutic Approach:
1994, when a few scientists found a hypothetical way of blocking multiple proteins simultaneously, they established Vitrobio with a 20-year R&D program. They used specific polymers to block & neutralize up to 57% histamine & 76% IgE on the nasal surface within 5-minutes.
These polymers were incorporated in a liquid filmogen solution (patented worldwide) to minimize the contact between the nasal mucosa & the allergen. (European PAEXA research award & French Academy of Science award).
15 ml spray for topical application on the nasal mucosa. Vitrobio name: ALLERSPRAY. Class I medical device in EU.
A double blind, randomized, placebo-controlled study was conducted in continuous allergen exposed AR suffering patients at Nexus Clinical Research. 31 patients were treated with Allerspray v/s 15 with saline solution, 3-4 applications per day for 3 weeks. Results show that Day 1 post dose (scoring made 30min after 1st product administration) effects are very marked. Day 2 mean rTNSS is comparable to Day 1 iTNSS, but all allergic rhinitis relief progresses continuously through week 3, indicating that unlike currently available anti-allergic drugs, Allerspray reduces progressively and effectively the allergen-induced symptomatic manifestations of rhinitis. Even after 3 weeks of treatment, there were no side effects or rebound effects, which is a big plus compared to existing drugs. Stopping allergen – nasal mucosa contact & simultaneously blocking histamine & IgE, consti
Shrivastava L et al: A new class of polymeric anti-allergen nasal barrier film solution for the treatment of allergic rhinitis (published in J. Allergy & Therapy, August 8:3, 2017.