Purdue’s Avrio Health L.P. Reports Preliminary In Vitro Test Results on Study Assessing Betadine Gargle Against COVID-19

THIS RELEASE DISCUSSES INVESTIGATIONAL USES OF BETADINE AND IS NOT INTENDED TO CONVEY CONCLUSIONS ABOUT ITS EFFICACY OR SAFETY IN TREATING AND/OR PREVENTING COVID-19 OR ANY OTHER VIRUSES. BETADINE ANTISEPTIC PRODUCTS HAVE NOT BEEN DEMONSTRATED TO BE EFFECTIVE AGAINST SARS-COV-2 OR ANY OTHER VIRUSES IN VIVO, NOR HAVE ANY CLINICAL STUDIES BEEN CONDUCTED TO ASSESS ITS SAFETY OR EFFECTIVENESS AS A VIRUCIDAL AGENT. THERE IS NO GUARANTEE THAT STUDIES EVALUATING THE EFFECTIVENESS OF BETADINE AGAINST THE VIRUS CAUSING COVID-19 WILL BE SUCCESSFUL.

Avrio Health L.P., a subsidiary of Purdue Pharma L.P. (“Purdue”), is reporting encouraging preliminary results of an in vitro (laboratory) study assessing Betadine® Antiseptic Sore Throat Gargle (active ingredient, povidone-iodine or “PVP-I”) against the virus causing COVID-19. Preliminary results show Betadine Gargle killed 99.9 percent of the virus within 15 seconds.

Betadine Gargle containing 0.5% PVP-I demonstrated virucidal activity against SARS-CoV-2 and four surrogate coronaviruses in three separate in vitro studies. An in vitro study conducted by Utah State University, Institute for Antiviral Research, assessed virucidal activity of Betadine Gargle against SARS-CoV-2. In this study, results showed a 99.9 percent reduction of SARS-CoV-2 viral load starting at 15 seconds and at all subsequent time points in the study (30 seconds, 60 seconds and 5 minutes).

Betadine Gargle was also studied against surrogate coronaviruses: Murine Hepatitis Virus Strain A59, a betacoronavirus within the subfamily Coronavirus, in a second study conducted by BluTest Laboratories, as well as human coronaviruses strains OC43 (alphacoronavirus), NL63 (alphacoronavirus), and 229E (betacoronavirus) in a third study conducted by Bioscience Laboratories. These two studies were conducted under ASTM E-1052- methods for measuring virucidal time kill to assess the activity of microbicides against viruses. In these two studies, results showed a 99.9 percent reduction in viral load starting at 15 seconds and at all subsequent time points (30 seconds, 60 seconds and 5 minutes).

“We are encouraged by these data as we continue to study PVP-I’s potential virucidal properties against the SARS-CoV-2 virus,” said Craig Landau, MD, president and CEO, Purdue Pharma. “Purdue and Avrio Health are committed to leveraging science to address public health needs, and to provide support during this uncharted public health emergency.”

Next, In vivo (human) studies will assess the safety and effectiveness of Betadine Gargle against SARS-CoV-2. Additionally, tests are being conducted on other Betadine formulations, as part of a comprehensive research program assessing the safety and effectiveness of Betadine Antiseptic products (Topical and Gargle) against COVID-19 that began in May.

Other studies on distinct international formulation:

Separately, in vitro studies conducted by the Tropical Infectious Diseases Research and Education Center at the University of Malaya, Malaysia, and at the Duke-NUS Medical School in Singapore, on a separate and distinct formulation of Betadine Gargle available abroad – but not in the U.S. – found that formulation of Betadine® Gargle (tested at 0.5% and 1.0% PVP-I) killed 99.99% of SARS-CoV-2 at the first timepoints measured.1,2

About Betadine

Betadine Topical Antiseptic products have been used in the hospital and outpatient setting for their antimicrobial properties for more than 50 years. Betadine Topical Antiseptic products currently available in the U.S. are for external use only and should not be gargled or swallowed. Betadine Antiseptic Sore Throat Gargle (0.5% povidone-iodine antiseptic gargle), which should not be swallowed, is an oral antiseptic with use for the temporary relief of occasional sore throat. Betadine Antiseptic Sore Throat Gargle will be available in retail stores in late August 2020. All products should be used only as directed on the label.

About Avrio Health L.P.

Avrio Health L.P., a subsidiary of Purdue Pharma L.P., is a consumer health products company that champions an improved quality of life for people in the United States through the reimagining of innovative product solutions. We have a strong portfolio of well-respected and proven effective brands, including Betadine®, Colace®, Senokot®, and SlowMag™ Mg.

About Purdue Pharma L.P.

Purdue Pharma and its subsidiaries develop and provide prescription medicines and consumer products that meet the evolving needs of healthcare professionals, patients, consumers and caregivers. We were founded by physicians and are currently led by a physician. Beyond our efforts to provide quality medications, Purdue Pharma is committed to supporting national, regional and local collaborations to drive innovations in patient care while also continuing our efforts to address the opioid crisis.

Purdue’s subsidiaries include: Adlon Therapeutics L.P., focused on treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) and related disorders; Avrio Health L.P., a consumer health products company that champions an improved quality of life for people in the United States through the reimagining of innovative product solutions; Imbrium Therapeutics L.P., established to further advance the emerging portfolio and develop the pipeline in the areas of CNS, non-opioid pain medicines, and select oncology through internal research, strategic collaborations and partnerships; and Greenfield Bioventures L.P., an investment vehicle focused on value-inflection in early stages of clinical development.

For more information, visit www.purduepharma.com.

1 Anderson, D.E., Sivalingam, V., Kang, A.E.Z. et al. Povidone-Iodine Demonstrates Rapid In Vitro Virucidal Activity Against SARS-CoV-2, The Virus Causing COVID-19 Disease. Infect Dis Ther (2020). https://doi.org/10.1007/s40121-020-00316-3

2 Hassandarvish, P., Tiong, V., Sazaly, A. et al. Povidone iodine gargle and mouthwash . Br Dent J 228, 900 (2020). https://doi.org/10.1038/s41415-020-1794-1

Contacts:

Michele Sharp
michele.sharp@pharma.com
(203) 585-3195

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