Rahul Majumdar

It is important to note that in vivo (human/animal) studies have not been conducted to evaluate the effectiveness of Betadine® antiseptics in the prevention or treatment of SARS-CoV-2 infection, nor have any human clinical studies been conducted to assess its safety or effectiveness as a virucidal agent.

Betadine® Antiseptic Oral Rinse (Povidone Iodine 0.5%) is used by healthcare professionals for pre-procedural preparation of the oral mucosa. This product should not be ingested. Use Betadine products only as directed on the label.

STAMFORD, Conn. – April 13, 2022 – Avrio Health L.P. and University of Pennsylvania have announced today that the University of Pennsylvania School of Dental Medicine Center for Clinical and Translational Research has been awarded an investigator-initiated research (IIR) grant from Avrio Health to investigate whether a povidone-iodine antiseptic oral rinse reduces the amount of SARS-CoV-2, the virus that causes COVID-19, in the mouth. The study includes Avrio’s Betadine® Antiseptic Oral Rinse, povidone-iodine 0.5% solution.

The study is currently enrolling eligible participants in a randomized, double-blind, parallel group, controlled clinical trial to evaluate the effect of povidone-iodine antiseptic oral rinse compared to a placebo oral rinse on reducing SARS-CoV-2 load in the mouth in COVID-19 positive individuals. The study plan is to enroll forty participants 18 years of age and older who are within five days of a positive COVID-19 test and have at least one clinical sign or symptom of COVID-19. During Phase 1, participants will attend one study visit where they will be asked to rinse/gargle with the assigned oral rinse and provide saliva and mouth swab samples. Interested participants will be invited to continue to Phase 2, during which participants will be given the povidone-iodine antiseptic oral rinse and asked to use it at home for one week followed by a final remote visit at the end of the week. Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT05239598.

“We are pleased to be continuing our commitment to supporting research into potential virucidal properties of Betadine against the SARS-CoV-2 virus,” said Julie Ducharme, BPharm, MSc, PhD, vice president and chief scientific officer, Purdue Pharma. “We look forward to learning more from this research program as the medical community continues to pursue scientific discovery to help address public health needs.”

This investigator-initiated research is being independently developed and implemented by Investigators at the University of Pennsylvania School of Dental Medicine via a research grant and Betadine oral antiseptic product provided by Avrio Health.

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. Betadine® Antiseptic Sore Throat Gargle (povidone iodine 0.5%), which should not be ingested, is used for the temporary relief of sore throat. Betadine® Antiseptic Oral Rinse (povidone iodine 0.5%) is used by healthcare professionals for pre-procedural preparation of the oral mucosa.

About Avrio Health L.P.
Avrio Health L.P., a subsidiary of Purdue Pharma, 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.

Penn Dental Medicine Center for Clinical and Translational Research

Penn Dental Medicine has a rich history as a research intensive institution and continues to be an international leader in the generation of new knowledge and treatment modalities to improve oral health. The Center for Clinical and Translational Research at Penn Dental Medicine advances human subjects research across disciplines to develop the clinical evidence needed to apply new technologies and treatments to patient care. The Center supports Penn Dental Medicine faculty across the full spectrum of clinical research from study conceptualization to closeout.

Media Contact:
Michele Sharp
(203) 588-7584

It is important to note that in vivo (human/animal) studies have not been conducted to evaluate the effectiveness of Betadine® antiseptics in the prevention or treatment of SARS-CoV-2 infection, nor have any human clinical studies been conducted to assess its safety or effectiveness as a virucidal agent.

Betadine® Antiseptic Oral Rinse (Povidone Iodine 0.5%) is used by healthcare professionals for pre-procedural preparation of the oral mucosa. This product should not be ingested. Use Betadine products only as directed on the label.

STAMFORD, Conn. – March 28, 2022 – Avrio Health L.P. today announced the publication of its manuscript, In vitro inactivation of SARS‑CoV‑2 using a povidone‑iodine oral rinse in the journal BioMed Central (BMC) Oral Health. The study was conducted at Utah State University, Institute for Antiviral Research and included Avrio’s Betadine® oral antiseptic product, povidone-iodine 0.5% solution.¹

The research demonstrated in vitro (cell culture) virucidal activity of 0.5% povidone iodine solution against SARS-CoV-2, the virus that causes COVID-19. Inactivation of SARS-CoV-2 was observed as early as 15 seconds after exposure to the povidone iodine solution.

“While clinical investigations are needed to assess the effectiveness of Betadine® Antiseptic Oral Rinse against SARS-CoV-2 in clinical practice, this study demonstrates promising initial results,” said Julie Ducharme, BPharm, MSc, PhD, vice president and chief scientific officer.

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. Betadine® Antiseptic Sore Throat Gargle (povidone iodine 0.5%), which should not be ingested, is used for the temporary relief of sore throat. Betadine® Antiseptic Oral Rinse (povidone iodine 0.5%) is used by healthcare professionals for pre-procedural preparation of the oral mucosa.

About Avrio Health L.P.
Avrio Health 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.

Media Contact:
Michele Sharp
(203) 588-7584

¹ Shet et al. BMC Oral Health (2022) 22:47 https://doi.org/10.1186/s12903-022-02082-9

Betadine® antiseptic products have not been demonstrated to be effective against infections caused by 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.

 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. Betadine Sore Throat Gargle (0.5% povidone-iodine antiseptic gargle), which should not be ingested, is used for the temporary relief of sore throat.

 STAMFORD, Conn. – Oct. 14, 2021 – Avrio Health L.P. today announced the publication of results from two in vitro laboratory studies assessing Betadine®antiseptic products (active ingredient: povidone-iodine or “PVP-I”) against four coronaviruses used as a surrogate for SARS-CoV-2. The studies, published in Infectious Diseases and Therapy, found that Betadine Topical Solution, Betadine Surgical Scrub, and Betadine Gargle demonstrated virucidal activity against the coronaviruses studied.

“While further data are needed, publication of these studies helps advance the knowledge of PVP-I’s potential virucidal properties,” said Julie Ducharme, BPharm, MSc, PhD, vice president and chief scientific officer. “Avrio Health is committed to scientific exploration to help inform health care provider response to public health needs.”

This in vitro research evaluated Betadine Topical Solution, Betadine Surgical Scrub, and Betadine Gargle against four coronaviruses used as surrogates to the SARS-CoV-2 virus: Murine Hepatitis Virus Strain A59, a betacoronavirus within the subfamily Coronavirinae-2; as well as human coronavirus strains OC43 (alphacoronavirus), NL63 (alphacoronavirus) and 229E (betacoronavirus) in a second study. These two studies were conducted under ASTM E-1052-11 methods for measuring virucidal time kill to assess the activity of microbicides against viruses.

Betadine Topical Solution (containing 5.0% and 10.0% PVP-I), Betadine Surgical Scrub (containing 7.5% PVP-I), and Betadine Gargle (containing 0.5% PVP-I) were compared to placebo in two separate in vitro studies and showed virucidal activity against four coronaviruses. Betadine Topical Solutions and Gargle showed a 99.99 percent (≥ 4 log) reduction of viral load against one or more strains starting at 15 seconds and at all subsequent time points (30 seconds, 60 seconds and 5 minutes). Results for Betadine Surgical Scrub showed a 99.9 percent (≥ 3 log) reduction across all strains in both studies starting at 15 seconds and at all other time points.¹

“These two studies are part of a research project assessing the safety and effectiveness of Betadine antiseptic products against coronaviruses. While the in vitro nature of the study design prevents clinical interpretation of the findings and further investigations are needed to evaluate SARS-CoV-2 inactivation, this work builds on the current body of knowledge intended to advance the science,” said Craig Landau, MD, president and CEO, Purdue Pharma.

These two studies were funded by Imbrium Therapeutics L.P., in collaboration with Avrio Health.

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. Betadine® Sore Throat Gargle (0.5% povidone-iodine antiseptic gargle), which should not be ingested, is used for the temporary relief of sore throat.

About Avrio Health L.P.

Avrio Health 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.

Media Contact:
Michele Sharp
(203) 588-7584

1. Shet, M., Hong, R., Igo, D. et al. In Vitro Evaluation of the Virucidal Activity of Different Povidone–Iodine Formulations Against Murine and Human Coronaviruses. Infect Dis Ther (2021). https://doi.org/10.1007/s40121-021-00536-1

STAMFORD, Conn. – Jun 17, 2021 – Avrio Health L.P., a subsidiary of Purdue Pharma L.P., today announced the launch of SlowMag® Mg Calm+Sleep, a dietary supplement with Magnesium Citrate and Melatonin. It supports relaxation, healthy sleep and waking up relaxed.*

SlowMag Mg Calm+Sleep comprises a unique combination of Magnesium and Melatonin that helps your body relax naturally as you drift off to healthy sleep, and promotes a sense of calm and relaxation.* It is formulated with an ideal level of melatonin so you wake up refreshed.* SlowMag Mg tablets are slow to digest. They feature a special enteric coating technology that is designed to reduce the chance of stomach upset. The launch of SlowMag Mg Calm+Sleep is an example of how Avrio Health continues to strengthen its core brand, SlowMag Mg.

This product will be available online and in retail stores this month.

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

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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, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, consumers and caregivers.

The company seeks to achieve a global bankruptcy settlement that would deliver more than $10 billion in value, including 100% of Purdue’s assets and millions of doses of opioid addiction treatment and overdose reversal medicines, to communities across the country to fund programs specifically for abatement of the opioid crisis.  The bankruptcy settlement will also deliver funds to private abatement trusts for the benefit of personal injury claimants.

If Purdue’s settlement is approved, Purdue’s assets will be transferred to a new company.  This new company will be governed by new independent board members, and will operate in a responsible and sustainable manner taking into account long-term public health interests relating to the opioid crisis. The company will continue serving patients and consumers who rely on its medicines and products, pursuing its pipeline, and introducing medicines that will help save and improve lives.

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

STAMFORD, Conn. – March 25, 2021 – Avrio Health L.P., a subsidiary of Purdue Pharma L.P., today announced the launch of two Senokot® Dietary Supplement Products: Senokot Laxative* Gummies – Blueberry Pomegranate flavor, and Senokot Laxative* Tea.

Senokot Dietary Supplement Laxative* Gummies – Blueberry Pomegranate flavor is a new flavor of Senokot Laxative* Gummies for gentle overnight relief of occasional constipation. ^†* Made from a natural senna plant, Senokot Laxative* Gummies are for occasional constipation relief.* This product is available online now, and in retail stores in June.

Senokot Dietary Supplement Laxative* Tea is a blend of natural and organic senna and chamomile that offers a sweet flavor with subtle cinnamon and floral notes. Relax with a cup before bedtime to provide overnight relief of occasional constipation. ^†* This product is available online in April and in retail stores in June.

These two products exemplify the ways in which Avrio Health continues to strengthen its core brand, Senokot.

^†When taken at bedtime
*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Additional Information

If pregnant, nursing or taking any medications, consult a healthcare professional before use. Do not take this product if you are allergic to any of the ingredients. Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Do not exceed the recommended amount or use this supplement for longer than 1 week unless directed by a doctor. Read the full product label before using.

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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 are physician-founded and physician-led companies that develop, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, consumers and caregivers. Purdue Pharma is also committed to driving innovations in patient care while continuing our efforts to address the opioid crisis.

Purdue’s subsidiaries include: Adlon Therapeutics L.P., focused on treatment options for Attention-Deficit/Hyperactivity Disorder (ADHD) and related disorders; Avrio Health L.P., a consumer wellness company that provides over-the-counter products to fight infection, promote digestive wellness and provide health supplements; Imbrium Therapeutics L.P., established to develop and commercialize non-opioid pain medications and therapies for select oncology and CNS disorders; Rhodes Pharmaceuticals L.P., which develops and supplies primarily solid oral-dose and transdermal medications; and Greenfield Bioventures L.P., an investment vehicle focused on compounds in the early stages of clinical development.

For more information, visit www.purduepharma.com.

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

STAMFORD, Conn. – February 08, 2021 – Avrio Health L.P. (Avrio), a subsidiary of Purdue Pharma L.P. (Purdue), today announced the launch of new Betadine^® Antiseptic Oral Rinse (active ingredient 0.5% povidone-iodine, or PVP-I), an oral antiseptic pre-procedural rinse. The product is for professional use only, and is not for retail sale. The Oral Rinse is available through your local dental distributor.

Betadine antiseptic products have been used in the hospital and outpatient settings for their antiseptic (antimicrobial) properties for more than 50 years.

Betadine^® Antiseptic Oral Rinse should be administered by professionals and used orally (do not swallow) in preparation of the oral mucosa prior to injection, dental surgery, or tooth extraction. Do not use this product for more than 7 days unless directed by a dentist or doctor. Do not use this product in children under 12 years of age unless directed by a dentist or doctor. Do not use this product if you are allergic to povidone-iodine or any other ingredients in this product, or if you have any thyroid conditions. For more information, visit www.Betadine.com.

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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. Betadine Sore Throat Gargle (0.5% povidone-iodine antiseptic gargle), which should not be ingested, is used for the temporary relief of sore throat.

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 are physician-founded and physician-led companies that develop, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, consumers and caregivers. Purdue Pharma is also committed to driving innovations in patient care while continuing our efforts to address the opioid crisis.

Purdue’s subsidiaries include: Adlon Therapeutics L.P., focused on treatment options for Attention-Deficit/Hyperactivity Disorder (ADHD) and related disorders; Avrio Health L.P., a consumer wellness company that provides over-the-counter products to fight infection, promote digestive wellness and provide health supplements; Imbrium Therapeutics L.P., established to develop and commercialize non-opioid pain medications and therapies for select oncology and CNS disorders; Rhodes Pharmaceuticals L.P., which develops and supplies primarily solid oral-dose and transdermal medications; and Greenfield Bioventures L.P., an investment vehicle focused on compounds in the early stages of clinical development.

For more information, visit www.purduepharma.com.

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