Purdue Pharma’s Avrio Health Begins Studies Assessing Betadine® (Povidone-Iodine) Antiseptic Products’ Safety and Effectiveness Against COVID-19

Program complements ongoing efforts to build understanding of potential virucidal properties of povidone-iodine against the virus causing COVID-19

STAMFORD, Conn.--(BUSINESS WIRE)-- Avrio Health L.P., a subsidiary of Purdue Pharma L.P. (“Purdue”), has initiated a program to evaluate the potential safety and virucidal effectiveness of certain formulations of Betadine® antiseptic products (active ingredient, povidone-iodine or “PVP-I”) against the virus causing COVID-19. An in vitro study evaluating activity against a surrogate coronavirus has begun, with additional in vitro and in vivo studies planned to evaluate certain formulations of Betadine antiseptic products.

Betadine antiseptic products are used to reduce the number of microorganisms on the skin that can potentially cause infection. Some of these products have been used by healthcare professionals for more than 50 years.

“Our Purdue and Avrio Health teams are passionate about contributing potential solutions that target COVID-19,” said Craig Landau, MD, president and CEO, Purdue Pharma. “We’re encouraged by emerging data, as well as the considerable published, peer-reviewed in vitro data that are available against other viruses in the coronavirus-family. Specifically, products containing PVP-I have previously demonstrated virucidal activity^1,2,3,4,5 in a laboratory setting against other coronaviruses, including severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).”

“While more data are needed, these in vitro data, combined with the recognized need for effective measures to prevent infection, support our decision to pursue our own fulsome research program. This initiative is a true reflection of our longstanding commitment to bringing important therapies forward at times of great need.”

Healthcare professionals, including nurses, doctors, respiratory therapists, EMTs and many others, have a markedly higher risk of becoming infected with COVID-19, especially if they are exposed to a high volume of sick patients (such as in the emergency room) or respiratory secretions (such as in the intensive care unit).⁶ Latest data from CDC indicate that more than 9,000 healthcare personnel have contracted COVID-19.⁷ In addition, continuous and often sustained exposure to COVID-19 positive patients represents significant risk to caregivers, their families, as well as non-infected patients.^6,8

Consistent with the ongoing U.S. Food and Drug Administration procedures for the evaluation of OTC antiseptic drug products, including those containing povidone-iodine, Betadine antiseptic products are available for use as labeled while additional data from these proposed studies are being generated.⁹

This release discusses investigational uses of Betadine and is not intended to convey conclusions about its efficacy or safety in reducing COVID-19 or any other viruses. Betadine antiseptic products have not been demonstrated to be effective against COVID-19 or any other viruses, 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 povidone-iodine against the virus causing COVID-19 will be successful.

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. Use 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 Eggers M, Eickmann M, Kowalski K, Zorn J, Reimer K. Povidone-iodine hand wash and hand rub products demonstrated excellent in vitro virucidal efficacy against Ebola virus and modified vaccinia virus Ankara, the new European test virus for enveloped viruses. BMC Infect Dis. 2015;15:375.

² Eggers M, Eickmann M, Zorn J. Rapid and effective virucidal activity of povidone-iodine products against middle east respiratory syndrome coronavirus (MERS-CoV) and modified vaccinia virus Ankara (MVA). Infect Dis Ther. 2015;4:491–501.

³ Eggers M, Koburger-Janssen T, Eickmann M, Zorn J. In vitro bactericidal and virucidal efficacy of povidone-iodine gargle/mouthwash against respiratory and oral tract pathogens. Infect Dis Ther 2018;7:249–259.

⁴ Kariwa H, Fujii N, Takashima I. Inactivation of SARS coronavirus by means of povidone-iodine, physical conditions and chemical reagents. Dermatology. 2006;212(Suppl 1):119–123.

⁵ Kawana R, Kitamura T, Nakagomi O, et al. Inactivation of human viruses by povidone-iodine in comparison with other antiseptics. Dermatology. 1997;195(suppl 2):29-35.

⁶ Harvard Health Blog, Harvard Medical School. What’s it like to be a healthcare worker in a pandemic? 2020. Accessed April 20, 2020. Retrieved from https://www.health.harvard.edu/blog/whats-it-like-to-be-a-healthcare-worker-in-a-pandemic-2020040819485.

⁷ Centers for Disease Control and Prevention (CDC). Characteristics of Health Care Personnel with COVID-19 — United States, February 12–April 9, 2020. MMWR Morb Mortal Wkly Rep 2020;69:477–481.

⁸ Centers for Disease Control and Prevention (CDC). Interim U.S. Guidance for Risk Assessment and Public Health Management of Healthcare Personnel with Potential Exposure in a Healthcare Setting to Patients with Coronavirus Disease 2019 (COVID-19). 2020. Accessed April 20, 2020. Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html.

⁹ U.S. Food and Drug Administration (FDA). Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. 2017. Accessed April 20, 2020. Retrieved from https://www.federalregister.gov/documents/2017/12/20/2017-27317/safety-and-effectiveness-of-health-care-antiseptics-topical-antimicrobial-drug-products-for.

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