FDA clears barrier nasal spray for mild allergic rhinitis
The Food and Drug Administration (FDA) has cleared Bentrio nasal spray ("Bentrio Allergy Blocker") for treatment of allergic rhinitis. The nasal spray alleviates mild allergic symptoms including mild nasal irritation including itchy, runny, or congested nasal passages triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, house dust, animal hair and dust mites.
Bentrio Allergy Blocker is a drug-free nasal spray for personal protection against airborne allergens. Upon application into the nose, Bentrio forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of allergens with cells; in addition, the composition serves to bind such particles and help with their discharge. Together, this is designed to reduce the risk of upper respiratory tract viral infections and promote alleviation of allergic symptoms.
Clearance was provided for the following indication for use: "Bentrio is intended to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e. mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, house dust, animal hair and dust mites.
Application of Bentrio produces a mucous-like gel barrier that coats the nasal membranes, traps inhaled allergens within the nasal cavity and helps with their clearance."
"We are excited by the opportunity created by the regulatory clearance of Bentrio Allergy Blocker for the US, which is by far the world's largest market for OTC consumer health products," said Thomas Meyer, Altamira Therapeutics' founder, Chairman and CEO. "Thanks to its triple mode of action, which does not require any drug ingredient for protecting against airborne allergens, and its preservative-free formulation, we believe that Bentrio is well positioned to help address unmet needs among the more than 20 million allergic rhinitis sufferers in the US. Over the next couple of years, we expect Bentrio to make substantial and growing contributions to our revenues and success."
Altamira's recently established OTC Consumer Health business unit expects to make the product available in the US later in the third quarter through one of the leading e-commerce platforms. It is actively in discussions with established OTC consumer health companies for exclusive distribution of Bentrio in the US as well as other key international markets.
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