PRESS RELEASE for distribution July 6, 2021
Two posters featuring highly significant head to head data for Wynzora® Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) vs Taclonex® Topical Suspension were shown at the Maui Derm NPPA Summer meeting from 23 to 26 June 2021.
- Wynzora uses PAD™ Technology to successfully combine calcipotriene and betamethasone diproprionate in the first and only water-based cream
- Wynzora achieved enhanced efficacy in a head-to-head study of 796 patients across 55 study sites1
- Wynzora also demonstrated significant reduction in itch as early as week 12
- Wynzora is approved for the topical treatment of plaque psoriasis in adults 18 years of age and older1
Wynzora® Cream will be available to US patients from 12 July 2021.
CHARLESTON, USA July 6, 2021 – EPI Health announced today the publication of two posters featuring data from the head to head Phase 3 pivotal study of Wynzora Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) versus vehicle and Taclonex Topical Suspension (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%). The data demonstrates that Wynzora Cream is significantly more effective than Taclonex Topical Suspension.
Wynzora Cream was evaluated in a phase 3, randomized, multicenter, investigator-blind trial comparing the efficacy and safety to vehicle and Tacolonex Topical Suspension, in adults with psoriasis. Subjects applied medication once daily for 8 weeks. The primary efficacy endpoint was the proportion of patients with treatment success at week 8, defined as a minimum 2-point decrease from baseline in Physician Global Assessment (PGA) score and “clear” or “almost clear” disease.
“The Wynzora head to head pivotal trial data demonstrated a highly significant difference in efficacy as compared to Taclonex Topical Suspension at week 4 (p<0.0001), with the delta increasing over the 8 week study. Wynzora also employs a novel delivery system called PAD Technology, which for the first time allows these active ingredients to be combined in a water-based cream” stated Mike Vecchiolla, Senior Director of Scientific Affairs at EPI Health.
As well as efficacy and safety, the study evaluated the impact of Wynzora treatment on an 11-point peak pruritus numeric rating scale (NRS). Itch reduction was evaluated by the absolute change in peak pruritus NRS score from baseline, with treatment success defined as a ≥4-point improvement. By week 1, 44% of patients had achieved treatment success2, increasing to 60.3% vs. 21.4% for vehicle at week 4 (p<0.0001)1.
“We have come to understand that itch has a tremendous impact on our psoriasis patients and affects their quality of life3. Wynzora has demonstrated highly statistically significant reduction of pruritus compared to vehicle as early as week 12” explained Dr Linda Stein Gold Director of Dermatology Clinical Research, Henry Ford Health System, Detroit, Michigan, principal investigator for the Phase 3 study.
The posters, entitled “Calcipotriene and betamethasone diproprionate cream demonstrates clinically meaningful improvement of itch associated with psoriasis” and “Calcipotriene and betamethasone diproprionate cream combines high efficacy, favorable safety and treatment preference in a single product for topical treatment of psoriasis” can be found at these links:
About Plaque Psoriasis
Psoriasis is a common, non-contagious, chronic skin disease, with no clear cause or cure. The negative impact of plaque psoriasis on people’s lives can be immense as it affects the appearance of the skin with red, scaly plaques. The appearance of flares of psoriasis can be unpredictable and affects people of all ages. With a reported prevalence of 2-4% of the population psoriasis constitutes a serious health problem with more than 100 million individuals affected worldwide. More than 90% of patients receiving treatment use topical drugs. According to the National Psoriasis Foundation, itch is present in between 70 and 90 percent of psoriasis patients, and together with flaking and scaling, itching is the most burdensome symptom to patients.3,4,5 Patients with psoriatic disease are at an elevated risk of developing other chronic and serious health conditions, including arthritis, cardiovascular diseases, metabolic syndrome, inflammatory bowel disease and depression.
About Wynzora Cream
Wynzora Cream is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis. Wynzora Cream is based on PAD Technology, which uniquely enables stability of both calcipotriene and betamethasone dipropionate in a convenient-to-use aqueous formulation. Wynzora Cream was uniquely designed to provide patients a new treatment option in their daily routines by combining the three essentials of a topical therapy in one single product: high efficacy, a favorable safety profile and convenience of use. The unique combination of all three essentials in topical therapy holds promise to less treatment discontinuation and overall better patient satisfaction in topical treatment of plaque psoriasis in a real-world setting. In the phase 3 trial conducted at multiple sites in the US, Wynzora Cream has demonstrated a unique combination of compelling clinical efficacy, a favorable safety profile and high convenience.
For more information, please visit www.wynzora.com.
1. Prescribing Information for Wynzora. Nov 2020.
2.Stein Gold L et al. J Drugs Dermatol. 2021 Apr 1;20(4):420-425
3 Strober B,et al. BMJ Open. 2019;9:e027535.
Wynzora® Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) Indication and ISI
Indication and Usage
Wynzora® (calcipotriene and betamethasone dipropionate) Cream is a prescription medicine indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.
Apply Wynzora® Cream to affected areas once daily for up to 8 weeks and not more than 100 grams per week. Patients should stop treatment when the plaque psoriasis is under control unless a healthcare provider gives other instructions.
Wynzora® Cream is for use on skin only (topical). Do not get Wynzora®
Cream near or in your mouth, eyes, or vagina. Avoid using Wynzora® Cream on your face, groin, or armpits, or if you have thinning of your skin (atrophy) at the treatment site.
It is not known if Wynzora® Cream is safe and effective in children.
Important Safety Information
Tell your healthcare provider about all your medical conditions and all the medicines you take, including any corticosteroid medicines and any other products containing calcipotriene.
Do not use other products containing calcipotriene or a corticosteroid medicine without talking to your healthcare provider first.
Wynzora® Cream may cause side effects, including:
● Too much calcium in your blood or urine and/or adrenal gland problems
● Cushing’s syndrome, a condition that happens when your body is exposed to large amounts of the hormone cortisol
● High blood sugar and sugar in your urine
● Vision problems, including an increased risk of developing cataracts and glaucoma.
The most common side effects include upper respiratory infection, headache, and application site irritation. These are not all the possible side effects. Call your healthcare provider for medical advice about side effects.
This summary is not comprehensive. Please visit www.wynzora.com to obtain the FDA approved 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, dermatolosis and now psoriasis.
For additional information please visit www.epihealth.com
About PAD™ Technology
PAD™ Technology formulations are tailor-made to meet the target product profile for a selected product candidate. PAD™ Technology enables the mixing of oil and water into a cream using just a fraction of the emulsifier required in conventional creams and lotions. Key features of PAD™ Technology formulations are high penetration of active ingredients to the target tissue, improved solubility and stability of active ingredients, high tolerability and excellent treatment convenience.
Contact information for EPI Health, Inc.
Samantha Widdicombe +1 949-331-0269