PRESS RELEASE for distribution August 31, 2021, 08:00 ET

Results of an expert roundtable meeting now published in Journal of Drugs in Dermatology concluded that dermatologists need to place greater emphasis on managing persistent facial erythema (or neurovascular dysregulation) of rosacea1.

  • It is estimated that 16 million Americans suffer from rosacea2
  • New guidance states that persistent facial erythema is now a primary diagnostic criteria for rosacea3 
  • In a large patient survey, persistent facial redness was reported to be the most troublesome symptom of rosacea4 
  • Rhofade®  (oxymetazoline 1% hydrochloride) cream is one of only two topical treatments approved by the FDA to treat this aspect of the disease1

CHARLESTON, USA, August 31, 2021 – EPI Health announced today the publication of the results of an expert roundtable meeting, conducted by the National Rosacea Society (NRS), in the Journal of Drugs and Dermatology.1 The roundtable was supported by an educational grant from EPI Health. 

A new classification system for rosacea was recently introduced, with a shift from the previous subtype approach to one that recognizes that rosacea is a single disorder with several potential phenotypes. It recognizes phymatous changes and the presence of erythema as being the primary diagnostic signs of the disease3. 

“We know from various studies and research that rosacea patients find their erythema very troublesome, and that it negatively affects their quality of life” explained Julie Harper MD of the Dermatology and Skin Care Center of Birmingham, Alabama, and immediate past President of the American Acne and Rosacea Society. “Despite this impact, facial erythema is often not taken seriously by physicians, even though we have therapies that can specifically address this aspect of the disease”.1 

The authors acknowledged that the initial patient visit may be lengthy, and that having a comprehensive treatment plan that patients adhere to can ensure they maintain remission from the signs of rosacea which may even help prevent progression of the disease. It was mentioned in the publication that long-term use of topical alpha adrenergic agonists (such as Rhofade® ) appeared to improve baseline (pre-dose) redness over time. 1

EPI Health is proud to support the dermatology community by enabling publications such as this, and the sharing of important information that can have a beneficial impact on patient management” shared Mike Vecchiolla, Head of Scientific Affairs for the company. “We appreciate our partnership with the NRS, and the resources they provide for patients with rosacea.”

About RHOFADE® Cream 

RHOFADE® is the only FDA-approved alpha 1 agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.

The National Rosacea Society (NRS) estimates that approximately 16 million Americans are affected by rosacea. Persistent facial redness (erythema) is cited as the most common sign of rosacea and may resemble a flushing or sunburn that does not go away. Typical triggers include sun exposure, stress, weather, food, and exercise. In an NRS survey, nearly 90% of rosacea patients said this condition had lowered their self-confidence and self-esteem, and 41% reported it had caused them to avoid public contact or cancel social engagements.1

For more information, please visit www.rhofade.com. 

RHOFADE® (oxymetazoline hydrochloride) cream, 1% Indication and ISI5

Indication

RHOFADE (oxymetazoline hydrochloride) cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Potential Impacts on Cardiovascular Disease
Alpha-adrenergic agonists may impact blood pressure. RHOFADE® should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension to seek immediate medical care if their condition worsens.

Potentiation of Vascular Insufficiency
RHOFADE should be used with caution in patients with cerebral or coronary insufficiency, Raynaud’s phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome.  Advise patients to seek immediate medical care if signs and symptoms of potentiation of vascular insufficiency develop.

Potential Impacts on Cardiovascular Disease
Alpha-adrenergic agonists may impact blood pressure. RHOFADE® should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension/hypotension to seek immediate medical care if their condition worsens.

RHOFADE may increase the risk of angle closure glaucoma in patients with narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute angle closure glaucoma develop.

ADVERSE REACTIONS

The most common adverse reactions for RHOFADE were: application site dermatitis 2 %, worsening inflammatory lesions of rosacea 1%, application site pruritus 1%, application site erythema 1%, and application site pain 1%.

This summary is not comprehensive. Please see www.RHOFADE.com for full Prescribing Information.

About EPI Health

Based in Charleston, South Carolina since 2017. EPI Health is committed to being a valued leader in dermatology by providing safe, beneficial, and effective medications to the dermatology community and the patients they serve, while enriching the lives of our employees through an enjoyable and rewarding and work environment. Our core values include Collaboration, Trust, Accountability and Transparency. Our wide portfolio of products serves the dermatology community across rosacea, acne, dermatosis and now psoriasis. 

For additional information please visit www.epihealth.com

1. Gallo et al. J Drugs Dermatol. 2021 Aug 1;20(8)

2. National Rosacea Society (https://www.rosacea.org)

3. Gallo et al J Am Acad Dermatol. 2018 Jan;78(1):148-155

4. Baldwin et al Dermatol Ther. 2019;9(4):725–734

5. Prescribing information for RHOFADE Nov 2019

Contact information for EPI Health, Inc.
Samantha Widdicombe  949-331-0269

swiddicombe@epihealth.com