Altamira Therapeutics (formerly Auris Medical) announced that the company has received 510(k) clearance to sell its Bentrio Allergy Blocker nasal spray over the counter for the treatment of allergic rhinitis in the US. The company said that it is in talks with “established OTC consumer health companies” regarding distribution of Bentrio in the US and elsewhere and expects to launch the product in the third quarter of this year “through one of the leading e-commerce platforms.” The nasal spray is already available in several countries in Europe and Asia.
Bentrio contains only inactive ingredients, with bentonite as the key component of the formulation. According to the company, the indication noted in the clearance includes the following explanation: “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.” Altamira has also said that studies of Bentrio against SARS-CoV-2, rhinoviruses, and influenza have yielded positive results.
Altamira Chairman and CEO Thomas Meyer commented, “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. 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.”
In addition to Bentrio, Altamira’s pipeline includes AM-125 betahistine nasal spray for the treatment of vertigo. In September 2020, the company reported positive results from a Phase 2a study of AM-125 in patients with acute vertigo after neurosurgery.
Read the Altamira Therapeutics press release.
