- Acceptance marks first regulatory filing with FDA since Absorica® in 2011 -
Cipher Pharmaceuticals Inc. (NASDAQ: CPHR; TSX:CPH) ("Cipher" or "the Company") today announced that it has received an Acceptance Review Notification for its 510(k) submission for Dermadexin™ to the U.S. Food & Drug Administration ("FDA"). The Notification confirms that the submission contains all of the necessary elements and information needed to proceed with the substantive review. Dermadexin™ is a patent-protected topical barrier-repair cream, targeting seborrheic dermatitis, an inflammatory skin disorder affecting the scalp, face, and torso, and contains the ingredient P3GCM.
Earlier this year, Cipher acquired the worldwide rights to Dermadexin™ and Pruridexin™, two late stage products, as well as ASF-1096, a product candidate in phase II, from Astion Pharma. All three products are focused on inflammatory dermatological diseases.
"The acceptance of our Dermadexin™ submission marks Cipher's first regulatory filing with the FDA since Absorica® in 2011," said Shawn Patrick O'Brien, President and CEO, Cipher Pharmaceuticals. "A key component of our strategy is to expand our U.S. portfolio of commercialized products and leverage our strong U.S. commercialization capability to accelerate growth. In addition to Dermadexin™, we are planning a 510(k) submission to the FDA for Pruridexin™ in the coming weeks. Each of these products represents an excellent opportunity to target common, chronic conditions that are insufficiently addressed today."
Dermadexin™ was approved in the European Union (EU) in 2014 as a Class III medical device for the alleviation of symptoms of facial dermatitis such as redness, scaling and itching.
SOURCE Cipher Pharmaceuticals Inc.