Applied Biological Laboratories (Applied Bio), a biopharmaceutical company focused on the respiratory disease market, announced that its study published online in Immunology, Inflammation and Disease was able to determine the mechanism behind respiratory inflammation and treat it effectively with Biovanta(TM), a 100% naturally derived, over-the-counter (OTC) drug for cold, cough and sore throat.
The study results also showed that almost all of the leading OTC products on the market can damage the upper respiratory cells and may prolong illness. This research study and its findings represent one of the first major breakthroughs in decades for the cold and flu market.
The study, titled "A Novel Anti-inflammatory Treatment for Bradykinin-induced Sore Throat or Pharyngitis," explored the efficacy of common OTC medications. Sore throat, or pharyngitis, is one of the most common symptoms of upper respiratory infection and a leading cause of physician visits and antibiotic prescriptions, but few, if any, OTC medications are proven to address sore throat inflammation.
The randomized, blinded, placebo-controlled study utilized state-of-the-art, fully developed human respiratory tissues (organoids) grown from nasal stem cells, stimulated with a molecule called bradykinin (one of the body's first inflammatory signals following an upper respiratory infection). Bradykinin uses Cox enzymes to stimulate more inflammatory molecules, such as prostoglandin. Once the mechanisms behind pharyngitis were understood, the cells were treated with a variety of OTC sore throat medications. Aspirin and a formula containing it as an active ingredient were also investigated as treatments and were found to be much more effective than any OTC treatment. Despite being a well-known Cox inhibitor, aspirin is not widely used for upper respiratory inflammation.
"Furthering our understanding of the mechanism behind respiratory inflammation is a key step in studying the effectiveness of common medications, and this study is profound because it also shows that ingredients commonly used in leading cough, cold and sore throat products like dextromethorphan, acetaminophen, guaifenesin and benzocaine are ineffectual and can even be toxic," said Alan Greene, MD, practicing physician and founder of DrGreene.com. "Alternatively, this study shows that the ingredients in Biovanta offer a safe and effective treatment for inflammation vs. a reduction of the symptoms."
Specific study results include:
- Of the 20 OTC products tested, all but one showed inflammatory and damaging effects on at least one of the measures tested, which were: level of prostaglandin E2 (PGE2) or interleukin 8 (IL-8) - key measures of inflammation, damage to the membrane barrier as measured by the electrical resistance across it and microscopy (through a microscope), and the release of lactate dehydrogenase (LDH), a chemical that is released by cells when they die.
- Biovanta, an OTC product with low-dose aspirin and other anti-inflammatory ingredients, reduced inflammation when applied to affected cells and tissues, making it the first scientifically proven 100% naturally derived, OTC medicine for treating cough, cold and sore throat.
- Aspirin can lower prostaglandin levels, but there is a small therapeutic window in which aspirin is anti-inflammatory when sprayed onto cells: 6 mg per dose. Below this the drug would not have a significant affect and above it, it becomes inflammatory. For comparison, a baby aspirin contains 81 mg.
This study is a major breakthrough in understanding the underlying mechanism of inflammation in upper respiratory illnesses, which wasn't possible until recent scientific advancements that enabled the creation of organoids for use in testing human tissue reactions. These scientifically proven results show that our groundbreaking formulas strengthen the respiratory barrier, unlike common OTC products, and we look forward to further demonstrating their effectiveness through a post-market real-world study."
Nazlie Latefi, PhD, Co-Founder and Chief Science Officer, Applied Bio
Leyva-Grado, V., et al. (2021) A novel anti-inflammatory treatment for bradykinin-induced sore throat or pharyngitis. Immunity, Inflammation and Disease. doi.org/10.1002/iid3.479.