Questions about nitric oxide

  1. What is nitric oxide?

    Nitric oxide (NO) is a well-understood, well-studied nano-molecule that naturally occurs in the body. It has several physiologic functions, including dilating blood vessels and helping regulate the body's immune response to infection. Its first therapeutic approval, in 1999, leveraged its selective vasodilatory effects for the hospital treatment of blue baby syndrome (persistent pulmonary hypertension of the newborn). Moreover, for decades, NO has also been studied for its potentially robust antimicrobial properties across a wide range of pathogens. Our studies show that when NO is delivered to a site of infection in the right dose (e.g. concentration and duration), it kills the pathogen, but is safe for the human cells.

  2. How does nitric oxide kill pathogens?

    Nitric oxide (NO) has multiple mechanisms of action (MOA) as an antimicrobial. As an antiviral, NO can prevent viruses from entering cells and replicating. NO rapidly inactivates the virus via conformational changes to the spike proteins and proteases, which lead to fast reduction in viral load. The molecule also has several MOA in single-celled organisms (bacteria and fungi), including DNA damage and inhibition of DNA repair, as well as lipid damage via lipid peroxidation, among others. These mechanisms make NO an effective antimicrobial, able to stand up to evolving variants and unlikely to lead to antimicrobial resistance. Importantly, NO can damage microbes at a dose that is safe for human cells.

Questions about nitric oxide nasal spray (NONSTM)

Please refer to the User Guide to answer your preliminary questions.

  1. Where can I purchase enovidTM/ VirX TM ?

    The nasal product is approved and available in select retail pharmacies in Israel, and Indonesia (under the brand name enovidTM) and in Thailand, Singapore, Hong Kong, South Africa, Malaysia, Cambodia, and Germany (under the brand name VirXTM ). It is also available in India, with prescription, under the name FabiSpray.

    This product is not yet available for sale in Canada or the United States.

  2. What is the difference between enovidTMand VirX TM?

    enovidTM and VirX TM are the identical product, branded under different names for marketing in various territories around the world. Nitric Oxide Nasal Spray (NONS) is the generic name of the product.

  3. Can I trust third party sellers such as Ebay or other websites?

    SaNOtize makes no representations or warranties, express or implied, and accepts no legal liability whatsoever with respect to any products not purchased directly from SaNOtize's authorized distributors or their retail outlets.

  4. What are the benchtop laboratory results showing the effectiveness of the spray against SARS-CoV-2 variants?

    In multiple laboratory experiments, nitric oxide (NO) released from SaNOtize's nasal spray formulation inactivated more than 99.9% of SARS-CoV-2 (COVID-19 isolates) to below the limit of detection, for all variants tested to date, within two minutes of contact.

    NO inactivates many key respiratory pathogens tested thus far. Prior to COVID-19 pandemic, this treatment was being developed as a flu prevention and was tested on Influenza (H1N1), RSV and Rhinovirus respiratory viruses (see graph below).

  5. What are the primary COVID-19 clinical study results?

    Nitric oxide released by nasal spray reduced SARS-CoV-2 log viral RNA load by more than 95% in infected participants within 24 hours of treatment, and by more than 99% in 48 to72 hours in two randomized, double blinded controlled studies. It was also shown to cut the time of positive (PCR) to negative by 50% in high-risk individuals (unvaccinated or over age 45 or with comorbidities).

    The Lancet, July 12, 2022: SARS-CoV-2 accelerated clearance using a novel nitric oxide nasal spray (NONS) treatment: A randomized trial

    Journal of Infection, May 13, 2021: Clinical efficacy of nitric oxide nasal spray (NONS) for the treatment of mild COVID-19 infection

    Respiratory Therapy, Spring 2023: Epidemiological Analysis of Nitric Oxide Nasal Spray (VirX™) Use in Students Exposed to COVID-19 Infected Individuals

    https://www.journalofinfection.com/article/S0163-4453(21)00251-6/fulltext

  6. How does enovidTM/ VirX TM work?

    SaNOtize has created a proprietary formulation that creates nitric oxide when the spray is released from the tip of the bottle. The spray has been formulated to create nitric oxide in a predictable and measurable dose with each spray.

    Click here to see a video of the mechanism of action.

  7. How do I use enovidTM/ VirX TM?

    Please refer to the User Guide.

    Please note that each box of the product is arriving with a User Guide insert that has instructions in a variety of languages. These may include Hebrew, English, Russian, Arabic, Thai, German, etc.

    A treatment consists of 2 alternating sprays per nostril for a total of 4 sprays per dose. As per user instructions, recommended dosing is 3 to 4 times daily as a preventative measure. Similar to using hand sanitizers, it should be used before and/or after potential exposure, up to 6 treatments per day. If you are experiencing any cold or flu like symptoms, we recommend using the spray more often; it can be safely used up to 6 treatments a day.

  8. Are there any known side effects?

    Please consult the User Guide insert in the box.

    It is recommended that if you experience reactions such as headache, nosebleed, or a persistent nasal burning sensation (that is, continues for > 5 minutes after each administration or is not tolerated), to discontinue using the product immediately. If symptoms persist, consult your Healthcare Provider.

  9. Can the spray be used in children?

    enovidTM/ VirX TM may be used in children 12 years and older. For children 11 years and younger, please consult your Healthcare Provider.

  10. Does enovid™/ VirX™ interfere with PCR or antigen tests for COVID-19?

    SaNOtize has conducted non-interference testing and has concluded that the common PCR assays and antigen kits are not affected by the product.

    These tests do not specifically test for live viruses. Rather they identify the presence of a virus, dead or alive, through the presence of structural virus spike protein or genetic material (RNA), at the time the test is performed. Much like fingerprints, the tests just demonstrate the presence of an individual (virus). If enovid™/ VirX™ has been used and a nasal swab is tested immediately after dosing, although the virus is inactivated, it will still produce a positive test. Even if all of the virus is inactivated.

  11. Is long-term safety data available?

    Although our clinical trial safety data and commercial pharmacovigilance monitoring data indicate a high benefit-to-risk (safe) product profile, we have not conducted a long-term safety analysis. Plans are in process to address a long-term safety assessment associated with the product's chronic use. Follow the directions for use as found in the User Guide insert.

  12. What are possible drug-drug interactions with enovid™/ VirX™?

    General drug-drug interactions:

    Due to the composition, local application, mechanical and physical-chemical mode of action, enovidTM / VirXTM is unlikely to be absorbed systemically. No interactions are known or expected with oral or parenteral medications.

    Nasal product interactions:

    Separate administration by 2 hours before and after applying enovidTM / VirXTM with other nasal products.

    Interactions with live attenuated nasal vaccines (LAIV, FluMist Quadrivalent):

    The co-administration of these products within the nasal cavity would be expected to inactivate live attenuated nasal vaccines. Do not use enovidTM / VirXTM, 1 day before and 7 days after receiving a live-attenuated influenza vaccine (LAIV) administered intranasally.

  13. Can the spray be used during pregnancy?

    Nitric Oxide Nasal Spray has not been studied in pregnant women. There are plans to include pregnant women in future clinical trials.

    Currently the product is contraindicated for use if pregnant or breast-feeding women. Consult a Healthcare Provider to discuss the possible benefits to risks to the fetus/baby if the product is required. For those planning on becoming pregnant, no fertility studies have been performed.

  14. Are there any harmful ingredients in the spray, such as steroids or graphene?

    The product does not contain steroids or graphene.

    The product contains sodium chloride, citric acid, HPMC, sodium nitrite, and benzalkonium chloride; along with the created nitric oxide upon actuation of the spray bottle. None are considered to be harmful.

  15. What are the preservatives used in the nasal spray?

    Benzalkonium chloride (0.01%).

  16. What is the shelf life (expiry) of an unopened bottle?

    Please use your bottle of enovidTM/ VirX TM before the date printed on the bottle.

  17. When does the spray expire once opened?

    The product's in-use stability of 60 days after opening is guaranteed.

  18. What do I do if there is a problem with the product, e.g., bottle malfunctioning?

    If a bottle malfunctions, the seal is broken or you have a problem with enovidTM/ VirX TM, please return it to the authorized location from which it was purchased to receive a replacement bottle.

  19. What should I do if I experience any health issues while using the spray?

    As per the enovidTM/ VirX TM User Guide, stop using the product and contact your Healthcare Provider (if necessary). All adverse events should be reported using the company's reporting system (info@sanotize.com).

  20. What is the difference between clinical and laboratory data?

    Experimental Laboratory Data - COVID-19 Virus Inactivation

    Text on the product's box refers to bench-top (in vitro) experimental laboratory data. The nitric oxide produced from SaNOtize's nasal spray formulation inactivated more than 99.9% of SARS-CoV-2 (COVID-19 isolated) to below the limit of detection within two minutes of contact. The same virucidal laboratory activity has been demonstrated against other respiratory viruses (influenza A [H1N1], HRV-14, and RSV).

    Clinical Study Data - Infected COVID-19 Participants

    Text from the website, and/or published clinical trials in the medical literature, describes nitric oxide released from SaNOtize's nasal spray formulation, which resulted in a rapid reduction (95%) in the SARS-CoV-2 viral load within 24 hours (Day 2), with a 99% reduction observed within 48 to 72 hours (Day 3 or Day 4 [depending on the trial]) from baseline, i.e., viral loads documented immediately before treatment (Day 1), in infected COVID-19 individuals participating in the randomized clinical trial.

    The Lancet, July 12 2022: SARS-CoV-2 accelerated clearance using a novel nitric oxide nasal spray (NONS) treatment: A randomized trial

    Journal of Infection, May 13 2021: Clinical efficacy of nitric oxide nasal spray (NONS) for the treatment of mild COVID-19 infection

    Respiratory Therapy, Spring 2023: Epidemiological Analysis of Nitric Oxide Nasal Spray (VirX™) Use in Students Exposed to COVID-19 Infected Individuals

  21. Why does my nose sting while using enovidTM/ VirX TM sometimes and other times it does not?

    As with many products that affect the 'senses', one can expect some variability in nasal tolerability, from day-to-day (inter-day) and often within the same day (intra-day), depending on one's method of preparation before use and during use of the product.

  22. What is the difference between nitric oxide and nitrous oxide?

    The product does not contain nitrous oxide (laughing gas/ Whippet / Hippy Crack / Nangs).

    Nitrous oxide (N2O) vs Nitric oxide (NO) Nasal Spray (NONS), please see here for a detailed description.

  23. How can I contact you if I have questions?

    Please contact one of our authorized distributors or email us at info@sanotize.com.