Sonoma Pharmaceuticals Announces Second FDA Approval to Add Antimicrobial Language to Alevicyn™ Gel Products for Management of Atopic Dermatitis
Second FDA approval in as many months further validates expanding adoption of Alevicyn products by dermatologists
PETALUMA, Calif., Dec. 05, 2017 (GLOBE NEWSWIRE) -- Sonoma Pharmaceuticals, Inc. (Nasdaq: SNOA, warrants SNOAW), a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded antimicrobial claim for the company’s key dermatology gel product, Alevicyn™ SG Antipruritic Spray Gel, reflecting the product’s widening clinical utility.
“With this second FDA approval now in hand, we’re pleased that both the Alevicyn Dermal Spray solution and gel products for the management of atopic dermatitis or eczema have expanded claims to include antimicrobial language and data demonstrating effectiveness against clinically relevant organisms,” said Jeff Day, president of Sonoma Pharmaceuticals’ dermatology division, IntraDerm Pharmaceuticals. “Our family of Alevicyn dermatology products can be prescribed with the confidence they are simultaneously safe, antimicrobial and efficacious in the management of various inflammatory skin dermatoses including atopic dermatitis and eczema.”
The first regulatory clearance to expand label language with antimicrobial claims was issued in November by the FDA for the Alevicyn Dermal Spray.
Alevicyn products, available via prescription, provide dermatologists with a safe and clinically proven approach to management of many inflammatory skin diseases, including atopic dermatitis—without the side effects of topical steroids and resistance issues associated with the overuse of antibiotics. In addition, the Alevicyn family of products are being used in both pre- and post-procedures, including skin cancer procedures. Over the last three years, there have been over 61,000 prescriptions filled for the Alevicyn family of products, valued at over $7.5 million. For more information visit www.alevicyn.com.
About the Global Dermatology Market
According to BCC Research, skin conditions are among the most common health problems in most national populations, collectively exceeding the prevalence of conditions such as obesity, hypertension and cancer. The considerable costs of skin diseases include physician visits, hospital care, prescription drugs and over-the-counter products for treating or managing these conditions, as well as indirect costs due to productivity losses.
The global market for skin disease treatment technologies is estimated to reach $20.4 billion in 2020. The U.S. market is the largest segment and should reach $8.6 billion in 2020.
About Sonoma Pharmaceuticals, Inc.
Sonoma is a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care. The company’s products, which are sold throughout the United States and internationally, have improved outcomes for more than five million patients globally by reducing infections, itch, pain, scarring and harmful inflammatory responses. The company's headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. European marketing and sales are headquartered in Roermond, Netherlands. More information can be found at www.sonomapharma.com.
Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial and technology progress and future financial performance of Sonoma Pharmaceuticals, Inc. and its subsidiaries (the “Company”). These forward-looking statements are identified by the use of words such as “believe,” “achieve,” and “strive,” among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, as well as uncertainties relative to varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission. The Company disclaims any obligation to update these forward-looking statements, except as required by law.
Sonoma®, Alevicyn™ and Microcyn® Technology are trademarks or registered trademarks of Sonoma Pharmaceuticals, Inc. All other trademarks and service marks are the property of their respective owners.
Media and Investor Contact:
Sonoma Pharmaceuticals, Inc.
VP of Public and Investor Relations
Released December 5, 2017