SAN DIEGO, Dec. 18 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. , a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, today announced it has begun dosing subjects in a Phase III clinical trial to evaluate intravenous acetaminophen (IV APAP) for the treatment of post-operative acute pain. The pivotal trial, referred to as CPI-APAP-301, is the second trial initiated as part of Cadence's clinical program to evaluate the efficacy and safety of IV APAP for pain and fever in adults and children. IV APAP has been marketed by Bristol-Myers Squibb Company in Europe since mid-2002, where it is now the market leader among injectable analgesics.
The CPI-APAP-301 study is randomized, double-blind, placebo controlled and will enroll 320 subjects who will be treated with either IV APAP or placebo in the 48-hour period following gynecologic surgery. The primary endpoint of the trial is analgesic efficacy as measured by reduction in pain intensity compared to placebo after eight doses given every six hours. The trial will be conducted at approximately 25 sites throughout the United States.
"Cadence's Phase III trial of IV APAP in gynecologic surgery signals the advancement of this exciting product into the pivotal stage of the clinical program required for marketing registration in the United States," said James Breitmeyer, M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer of Cadence. "There is a significant unmet need among surgical patients and the anesthesiologists and surgeons who treat post-operative pain for an effective non-opioid IV analgesic without the unwanted side effects associated with currently available treatments. Our objective for Cadence's clinical program is to demonstrate that IV APAP is able to fulfill this important unmet need."
Cadence's clinical development program for IV APAP registration will enroll approximately 750 patients in two Phase III efficacy trials (gynecologic surgery and fever), two safety trials (adults and children) and two pharmacokinetic trials (children and adults), the latter of which was initiated in October. The remaining trials are expected to begin enrollment in 2007. Cadence expects to submit a 505(b)(2) new drug application (NDA) to the U.S. Food and Drug Administration in the second half of 2008 requesting marketing approval of IV APAP for pain and fever in adults and children, assuming successful completion of the planned clinical trials. This NDA will include data from both Cadence's and Bristol-Myers Squibb Company's clinical development programs and will reference data from other currently marketed products containing acetaminophen, of which there are more than 300 in the United States.
About IV APAP
IV APAP is a proprietary intravenous formulation of acetaminophen. Acetaminophen in oral form is the most widely used medication in history for the treatment of pain and fever. Before the development of IV APAP, poor stability in aqueous solutions and inadequate solubility of acetaminophen had prevented the development of an intravenous dosage form. IV APAP has previously been studied in six completed Phase III trials, and Bristol-Myers Squibb has marketed the product in Europe since mid-2002, where over 150 million doses of the drug have been prescribed and IV APAP is the market leader in terms of both dollars and units sold among all injectable analgesics. In the United States, opioids and ketorolac (a non steroidal anti-inflammatory drug), currently the only intravenous analgesics available to treat acute post-operative pain, may be associated with significant adverse side-effects.
About Cadence Pharmaceuticals, Inc.
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 currently has two Phase III products in development, including IV APAP, (acetaminophen for injection) for the treatment of acute pain and fever, and Omigard(TM) (omiganan pentahydrochloride 1% aqueous gel) for the prevention of catheter- related infections. For more information about Cadence's pipeline, visit www.cadencepharm.com.
Forward-Looking Statements
Cadence cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements 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 release due to the risks and uncertainties inherent in Cadence's business, including, without limitation: anticipated timing of initiation or completion of ongoing or planned clinical trials; the adequacy of the clinical trial design to support regulatory approvals in the stated indications or at all; the potential for IV APAP to receive regulatory approval for one or more indications on a timely basis or at all; unexpected adverse side effects or inadequate therapeutic efficacy of IV APAP that could delay or prevent regulatory approval or commercialization, or that could result in recalls or product liability claims; other difficulties or delays in development, testing, manufacturing and marketing of and obtaining regulatory approval for IV APAP; the scope and validity of patent protection for IV APAP; and other risks detailed in Cadence's prior press releases as well as in Cadence's 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 news 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 and Omigard(TM) is a registered trademark of Cadence Pharmaceuticals, Inc.
Contacts: William R. LaRue Susan Neath SVP & Chief Financial Officer Media & Investor Relations Cadence Pharmaceuticals, Inc. Porter Novelli Life Sciences 858-436-1400 619-849-6007
Cadence Pharmaceuticals, Inc.CONTACT: William R. LaRue, SVP & Chief Financial Officer of CadencePharmaceuticals, Inc., +1-858-436-1400; or Susan Neath of Porter NovelliLife Sciences, +1-619-849-6007, Media & Investor Relations for CadencePharmaceuticals, Inc.
Web site: http://www.cadencepharm.com/
