MISSISSAUGA, ON, Nov. 23, 2011 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced that it has submitted an amendment to its pending New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CIP-ISOTRETINOIN, its novel, patented formulation of the acne medication isotretinoin. Cipher is seeking approval to market CIP-ISOTRETINOIN for the treatment of severe, nodular acne.
Cipher's NDA amendment provides additional clinical information requested by the FDA in support of obtaining approval. Subject to FDA acceptance as a complete response to its outstanding comments, Cipher expects the review under the Prescription Drug User Fee Act (PDUFA) to be completed in six months.
FDA acceptance as a complete response will trigger a US$1.0 million milestone payment from Cipher's marketing partner.
In the pharmacokinetic studies that formed the basis of its original NDA, CIP-ISOTRETINOIN demonstrated more consistent absorption under variable dietary conditions compared with existing isotretinoin products. To achieve optimal absorption, current isotretinoin formulations are prescribed to be taken with meals, which proves to be a compliance challenge for many teenagers. CIP-ISOTRETINOIN uses the patent-protected Lidose® drug delivery system, which delivers more consistent bioavailability for relatively water-insoluble compounds. Cipher was issued a patent for CIP-ISOTRETINOIN by the United States Patent and Trademark Office in 2008.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals is a growing specialty pharmaceutical company that commercializes novel formulations of successful, currently marketed molecules. Cipher's strategy is to in-license clearly differentiated products, advance them through the clinical development and regulatory approval stages, and out-license to international marketing partners. The Company's first product is a fenofibrate formulation marketed in the United States as Lipofen®. Cipher's second product, an extended-release tramadol, is marketed in the United States as ConZip™ and will be marketed in Canada as Durela™. The Company's third product, a novel formulation of the acne treatment isotretinoin, recently completed its final Phase III safety study, with regulatory submissions planned in the United States and Canada in Q4, 2011.
Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding. For more information, please visit www.cipherpharma.com.
For further information:
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