Navigation Links
Cipher receives tentative FDA approval for extended-release tramadol capsules
Date:2/17/2009

Toronto Stock Exchange Symbol: DND

MISSISSAUGA, ON, Feb. 17 /PRNewswire-FirstCall/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for CIP-TRAMADOL ER, the Company's extended-release formulation of the analgesic tramadol, which is indicated for the management of moderate to moderately severe chronic pain such as osteoarthritis. While the product meets all the FDA's requirements for manufacturing quality, clinical safety and efficacy, the Company must resolve certain patent issues related to the reference product, Ultram(R) ER, before CIP-TRAMADOL ER is commercialized.

"Tentative approval of our extended-release tramadol is another important achievement for our organization and validates the safety and efficacy of this product, which has an attractive profile for a chronic pain medication," said Larry Andrews, President and CEO of Cipher. "We are working diligently on the remaining steps toward commercialization, including securing a U.S. marketing partner and addressing the outstanding intellectual property issues."

Cipher's revised New Drug Application (NDA) for CIP-TRAMADOL ER was submitted in Q2 2008 as a 505(b)(2) application. Since there are issued U.S. patents for the approved product held by a third party, Cipher was required to certify to the FDA concerning any patents listed in the FDA's Orange Book publication at the time of submission. Cipher's application contained a paragraph III certification acknowledging that the listed patent had not expired and that final approval would be sought after patent expiration in 2014. A paragraph IV certification, which states that the listed patent is invalid, unenforceable, or will not be infringed by the manufacture or sale of the drug, may trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act. To date, this certification has not been filed.

CIP-TRAMADOL ER capsules are based on patented oral controlled-release bead technology and feature both immediate-release and extended-release properties.

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. 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. The product is being marketed in the United States by Kowa Pharmaceuticals America under the label Lipofen(R). In addition, Cipher is developing formulations of the pain reliever tramadol (tentative FDA approval in February 2009) and the acne treatment isotretinoin (FDA approvable letter in April 2007).

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.

Forward-Looking Statements

Statements made in this news release, other than those concerning historical financial information, may be forward-looking and therefore subject to various risks and uncertainties. Some forward-looking statements may be identified by words like "may", "will", "anticipate", "estimate", "expect", "intend", or "continue" or the negative thereof or similar variations. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. Factors that could cause results to vary include those identified in the Company's Annual Information Form and other filings with Canadian securities regulatory authorities, such as the applicability of patents and proprietary technology; possible patent litigation; regulatory approval of products in the Company's pipeline; changes in government regulation or regulatory approval processes; government and third-party payer reimbursement; dependence on strategic partnerships for product candidates and technologies, marketing and R&D services; meeting projected drug development timelines and goals; intensifying competition; rapid technological change in the pharmaceutical industry; anticipated future losses; the ability to access capital to fund R&D; and the ability to attract and retain key personnel. All forward-looking statements presented herein should be considered in conjunction with such filings. Except as required by Canadian securities laws, the Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.


'/>"/>
SOURCE Cipher Pharmaceuticals Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Deciphering the bodys healing secrets
2. Deciphering the Language of Intoxication
3. Cipher Pharmaceuticals announces U.S. distribution and supply agreement with Ranbaxy for CIP-ISOTRETINOIN
4. Ciphers revised NDA for CIP-TRAMADOL ER accepted for review by FDA
5. Cipher provides regulatory update for CIP-TRAMADOL ER
6. Cipher provides CIP-TRAMADOL ER regulatory update
7. Cipher appoints Stefan Aigner to board of directors
8. Cipher Appeals FDAs Decision On CIP-TRAMADOL ER
9. Cipher reports third quarter fiscal 2007 results
10. China Shenghuo Receives Notice from NYSE Alternext US Regarding Listing Standards
11. A Drug That Receives Regulatory Approval for Cognitive Impairment Associated With Schizophrenia Would Earn a Higher Patient Share in the United States Than in Europe
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2017)... ... July 28, 2017 , ... ... of its budget on nutrition assistance programs. , Right now the most public ... . However, changes to other programs are under consideration, including WIC (Women, Infants, ...
(Date:7/28/2017)... ... July 28, 2017 , ... Kevin Harrington, one of the original Sharks from hit reality ... of a new DRTV campaign with My Real Earth. , Most people put their healthcare ... just as important as what we put in our bodies. After all, the skin is ...
(Date:7/28/2017)... OR (PRWEB) , ... July 28, 2017 , ... Date ... http://www.GlobalDragonTV.com , Like millions of first generation immigrants before her, Rose Hong ... beneficiary of generosity and sacrifice on the part of loving parents who made sure ...
(Date:7/28/2017)... ... 2017 , ... The DuPage County law firm of Mirabella Kincaid Frederick ... Ms. Cusack joins the team ready to provide clients with vigorous representation in ... in Peoria, Illinois, with a BA in Social Work. She earned her JD from ...
(Date:7/28/2017)... ... July 28, 2017 , ... As many parents, students, and teachers are getting ... sharpen mental acuity and address mental fatigue that can accompany long study hours, homework ... that can not only helps with school work but also in day-to-day functions on ...
Breaking Medicine News(10 mins):
(Date:7/28/2017)... CHICAGO, July 28, 2017 Hill-Rom Holdings, Inc. ... fiscal third quarter ended June 30, 2017, and updated ... For the fiscal third quarter, ... to $0.68 per diluted share in the prior-year period. ... of $0.39 per diluted share primarily related to the ...
(Date:7/28/2017)... , July 28, 2017 EnvoyHealth, a Diplomat company, ... a program for CleverCap LITE, a technology designed to ... to deliver innovative health technology solutions and services that ... CleverCap LITE offers medication monitoring ... bottle cover: Records ...
(Date:7/27/2017)... -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today reported ... The Company reported second quarter net sales of $1.954 ... period, and an increase of 2.1% on a constant ... from the LDR Holding Corporation acquisition, second quarter 2017 ... or 0.3% on a constant currency basis. ...
Breaking Medicine Technology: