Encore Dermatology Inc. Announces the Launch of IMPOYZTM (clobetasol propionate) Cream, 0.025%, a Newly Formulated High-Potency Topical Corticosteroid

MALVERN, Pa.--(BUSINESS WIRE)-- Encore Dermatology Inc. announces today the availability of a new topical product, IMPOYZ Cream, indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age or older. IMPOYZ Cream is the only FDA-approved high-potency topical corticosteroid with 0.025% clobetasol propionate.

For over 30 years, clobetasol propionate has been available in only one strength. “Now we are especially excited to launch IMPOYZ Cream, as it offers dermatology providers with their first new strength as an alternative to traditional clobetasol – allowing providers to treat their patients with a lower concentration,” said Bob Moccia, president and CEO of Encore Dermatology.

IMPOYZ Cream contains clobetasol propionate 0.025% in a modern vehicle. This specially formulated product is effective in reducing the signs and symptoms of plaque psoriasis while offering a favorable tolerability and safety profile. The active ingredient in IMPOYZ Cream, clobetasol propionate, is one of the most widely used corticosteroids for the treatment of psoriasis.

“Psoriasis patients are some of the most challenging to treat because of the chronic nature of the disease and the effect it has on their quality of life,” said Mark Lebwohl, MD, Professor and Chairman of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai. “IMPOYZ Cream gives dermatology providers the opportunity to treat moderate to severe psoriasis patients with an active ingredient they know well in a new, modern formulation.”

Encore Dermatology is dedicated to offering a wide variety of dermatology products to aid providers in managing the patients they see most. According to Moccia, the addition of IMPOYZ Cream is an important milestone for Encore Dermatology, as it is the first of what the company hopes will be many New Drug Application (NDA) products Encore plans to launch.

“The launch of IMPOYZ Cream is significant. It allows Encore to provide a new treatment solution to dermatologists for their patients with psoriasis. IMPOYZ Cream now takes its place along with other Encore products for the treatment of acne and eczema,” Moccia said. “Moving forward, Encore will be one of only a few specialty medical dermatology companies bringing new and innovative products to the market.”

IMPOYZ Cream is available in the U.S. by prescription only in a 60g tube.

Important Safety Information for IMPOYZ (clobetasol propionate) Cream, 0.025%

Warnings and Precautions

  • Topical corticosteroids, including IMPOYZ Cream, can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment.
  • This may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose to HPA axis suppression include use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.
  • If HPA axis suppression occurs, gradually withdraw the drug, reduce frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of withdrawal occur, systemic corticosteroids may be required. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
  • Although rare, systemic effects of topical corticosteroids may manifest as Cushing’s syndrome, hyperglycemia, and glucosuria.
  • Pediatric patients may be more susceptible to systemic toxicity because of their larger skin surface to body mass ratios.

Local Adverse Reactions with Topical Corticosteroids

  • Local adverse reactions from topical corticosteroids may be more likely to occur with occlusion, prolonged use, or use of higher-potency corticosteroids. Some local adverse reactions may be irreversible.

Concomitant Skin Infections

  • Use an appropriate antimicrobial agent if a skin infection is present or develops. If appropriate, discontinue use of IMPOYZ Cream.

Allergic Contact Dermatitis

  • Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation.

Adverse Events

  • The adverse reaction that occurred in at least 1% of subjects treated with IMPOYZ Cream and at a higher incidence than in subjects treated with vehicle cream was application site discoloration (2% versus 1%). Less common local adverse events occurring in < 1% of subjects treated with IMPOYZ Cream were application site atrophy, telangiectasia and rash.

Please see Full Prescribing Information for additional information.

Reference: Prescribing Information for IMPOYZ Cream. Encore Dermatology, Inc., Malvern, PA.

About Encore Dermatology Inc.

Headquartered in Malvern, Pennsylvania, Encore Dermatology is a privately held, fully integrated specialty dermatology company committed to delivering innovative prescription therapies and medical devices to dermatologists while focusing on customer service and improving the quality of life of patients. In addition to the founders, Encore Dermatology’s principal investors are Essex Woodlands, 1315 Capital and Longitude Capital.

Dr. Lebwohl has received compensation as a consultant for participating on the Encore advisory board.

Contacts

Encore Dermatology Inc.
Kent Taylor, 610-232-5455
VP Marketing
ktaylor@encorederm.com

 

 
 

Source: Encore Dermatology Inc.

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