OfirmevTreatment for Pain, Fever
Update: Ofirmev (intravenous acetaminophen) Now FDA Approved - November 2, 2010
Cadence Pharmaceuticals Announces FDA Extends New Drug Application Review for Intravenous Acetaminophen by Three Months
SAN DIEGO, Calif., Nov. 13 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the New Drug Application (NDA) for intravenous (IV) acetaminophen by three months. The extended PDUFA goal date is February 12, 2010.
"We remain confident in our NDA submission and will continue to work closely with the FDA toward the potential approval of intravenous acetaminophen," said Ted Schroeder, President and Chief Executive Officer of Cadence. "We are now planning for a launch early in the second quarter of 2010 and continuing to move forward with all of our commercial readiness activities, including recruitment of our sales force."
The FDA designated one of Cadence's submissions to the NDA, which contained additional clinical pharmacology data requested by the agency during the review process, as a major amendment. The FDA has the option to extend the PDUFA goal date when a sponsor submits a major amendment to an NDA within three months of the PDUFA goal date to provide time to complete the review. The FDA is not requesting any other information at this time.
About IV Acetaminophen
IV acetaminophen is Cadence's proprietary intravenous formulation of acetaminophen. Acetaminophen is the most widely used medication for the treatment of pain and fever in the United States and is available in more than 600 combination and single-ingredient prescription and over-the-counter products. Cadence acquired the exclusive rights to the proprietary intravenous form of acetaminophen in the United States and Canada in 2006 from Bristol-Myers Squibb Company, which markets the product as Perfalgan® in Europe and other parts of the world. IV acetaminophen is approved in approximately 80 countries, including major markets in Europe, where it is the market leader among all injectable analgesics. Approximately 90 million vials of IV acetaminophen were sold in Europe in 2008 representing an increase of approximately 13% over 2007.
The NDA for IV acetaminophen includes data from one pivotal clinical trial for the treatment of acute pain in patients following orthopedic surgery and one pivotal clinical trial for the treatment of fever. The NDA is further supported by data from a total of nine placebo-controlled clinical trials, four active-controlled clinical trials, and seven other safety or pharmacokinetic clinical trials. The submission includes safety data from over 1,400 patients who received IV acetaminophen in clinical trials, including 350 pediatric patients, from premature neonates to adolescents, and data from safety reports that collectively represent more than 53 million patient exposures to IV acetaminophen in countries outside the United States.
Conference Call and Webcast on November 13, 2009 at 5:30 a.m. Pacific Time (8:30 a.m. Eastern Time)
Cadence management will host a conference call on November 13, 2009 at 5:30 a.m. Pacific Time (8:30 a.m. Eastern Time) and interested investors may participate in the conference call by dialing 800-967-7137 (domestic) or 719-785-9446 (international). To access the webcast, please visit the company's website at www.cadencepharm.com and go to the Investor Relations page. A replay of the webcast will be available approximately two hours after the call and remain available on the company's website until the next quarterly financial results call.
Cadence Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting. The company is currently developing IV acetaminophen, an investigational product candidate for the treatment of acute pain and fever. For more information about Cadence, please visit www.cadencepharm.com.
Statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "expects," "anticipates," "planning," "will," and "potential," and similar expressions, are intended to identify forward-looking statements, and are based on Cadence's current beliefs and expectations. Forward-looking statements include statements regarding: the potential that the FDA will approve Cadence's NDA for IV acetaminophen by the extended PDUFA goal date; the company's plans to accelerate the development of its commercial and supply operations infrastructure; and the timing of the launch of IV acetaminophen. The inclusion of forward-looking statements such as these should not be regarded as a representation by Cadence that any of its plans will be achieved. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the company's business, including, without limitation: the possibility that the FDA may not approve the NDA for IV acetaminophen if the agency determines that the clinical, non-clinical or other data submitted in the NDA are not adequate to support the safety or efficacy of this product candidate, or the agency may require us to conduct additional studies or clinical trials; the possibility that pre-approval inspections by the FDA of the site where IV acetaminophen is manufactured, or Cadence's clinical trial sites, may raise issues that must be resolved prior to obtaining approval of the NDA; the risk that increased attention to drug safety issues may result in a more cautious approach by the FDA, which could delay the completion of the review process for the IV acetaminophen NDA, or result in limitations in the indications for use or the inclusion of unfavorable information in the labeling for this product candidate; intense competition from existing and new products, which could diminish the commercial potential for IV acetaminophen; the possibility that the patent rights covering IV acetaminophen may not be sufficient to preclude other intravenous formulations of acetaminophen from being developed by competitors; the company's dependence on IV acetaminophen, which is Cadence's only product candidate; the potential for Cadence to require substantial additional funding in order to obtain regulatory approval for and commercialize IV acetaminophen, and the risk that the company may not be able to raise sufficient capital when needed, or at all; and other risks detailed in Cadence's prior press releases as well as in Cadence's periodic public filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Cadence undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Cadence(TM) is a trademark of Cadence Pharmaceuticals, Inc. Perfalgan® is a registered trademark of Bristol-Myers Squibb Company.
Contact: William R. LaRue SVP & Chief Financial Officer Cadence Pharmaceuticals, Inc. 858-436-1400
Source: Cadence Pharmaceuticals, Inc.
Posted: November 2009
- Cadence Pharmaceuticals Announces FDA Approval of Ofirmev (acetaminophen) injection for the Management of Pain and Fever - November 3, 2010
- Cadence Pharmaceuticals Announces Ofirmev NDA Action Date of November 4, 2010 - May 17, 2010
- Cadence Pharmaceuticals Resubmits New Drug Application for Ofirmev - May 5, 2010
- Cadence Pharmaceuticals Announces Plan to Resubmit NDA for Ofirmev - April 19, 2010
- Cadence Pharmaceuticals Receives Complete Response Letter from FDA for Intravenous Acetaminophen NDA - February 11, 2010
- Cadence Pharmaceuticals Announces Priority Review and Acceptance of NDA Submission for Acetavance for Treatment of Acute Pain and Fever - July 15, 2009
- Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever - May 13, 2009
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