Healthcare Industry News: tretinoin
News Release - June 29, 2006
Cipher submits NDA for once-daily TRAMADOL formulation
MISSISSAUGA, ON, June 29 (Healthcare Sales & Marketing Network) - Cipher Pharmaceuticals Inc. (TSX: DND ) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CIP-TRAMADOL ER, an extended-release capsule formulation of the pain medication tramadol. Cipher is seeking approval to market CIP-TRAMADOL ER for the treatment of moderate to moderately severe pain.Cipher's CIP-TRAMADOL ER NDA contains data from six completed pharmacokinetic studies and five Phase III studies (three of these providing pivotal efficacy data and two providing long-term safety data). Cipher was originally advised by the FDA that its submission would require an additional Phase III study, which the Company initiated in 2005. However, as previously disclosed in January, 2006, the FDA subsequently informed Cipher that its existing clinical data package met the requirements to file an NDA. Cipher decided to complete the additional Phase III study to further support the regulatory and commercial success of the product. The Company expects to have the results of the study in the third quarter of 2006. Approximately 2,600 patients have participated in Phase III studies, with more than 2,000 patients having received CIP-TRAMADOL ER.
"This represents another important milestone on the path to commercialization of our once-daily tramadol and the third NDA we have submitted to the FDA from our late-stage product pipeline," said Larry Andrews, President of Cipher Pharmaceuticals. "Our NDA for CIP-TRAMADOL ER is supported by a comprehensive data package that shows the product's key attributes - including rapid absorption, sustainable therapeutic plasma levels at 24 hours and comparable absorption under fed and fasted conditions - which we believe would make it an attractive treatment option in the large but underserved pain management market."
About CIP-TRAMADOL ER
Tramadol is a synthetic opioid that is used to treat moderate to moderately severe pain, which is commonly associated with osteoarthritis, without the severe side-effect profile of morphine and other opioids. Cipher's CIP-TRAMADOL ER capsule is a novel formulation that delivers sustained-release drug delivery properties with once-daily dosing. CIP-TRAMADOL ER uses oral controlled-release bead technology developed by Cipher's technology partner, Galephar Pharmaceutical Research.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals is a drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies. Cipher's strategy is to in-license products that incorporate proven drug delivery technologies and advance them through the clinical development and regulatory approval stages, after which the products are out-licensed to international partners. Because Cipher's products are based on proven technology platforms applied to currently marketed drugs, they are expected to have lower approval risk, shorter development timelines and significantly lower development costs. Cipher currently has three late-stage drugs in its pipeline. The Company's lead compound, CIP-FENOFIBRATE, received final approval from the U.S. Food and Drug Administration and Health Canada in the first quarter of 2006. In addition, Cipher is developing formulations of the pain reliever tramadol and the acne treatment isotretinoin.
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.
Statements made in this news release, other than those concerning historical financial information, should be considered forward-looking and subject to various risks and uncertainties. Such forward-looking statements are based on management's beliefs and assumptions regarding the information currently available. The Company's actual results could differ materially from those expressed in the forward-looking statements. Factors that could cause results to vary include, among other things, those expressed in the Company's filings with Canadian securities regulatory authorities. All information presented herein should be read in conjunction with such filings.
Source: Cipher Pharmaceuticals
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