Cadence Pharmaceuticals, Inc. (NASDAQ:CADX) today announced that it has received written guidance from the U.S. Food and Drug Administration (FDA) that one post-operative pain trial (Sinatra Study) and one fever trial (Study 302) are sufficient to meet the pivotal clinical trial requirements for submission of a New Drug Application (NDA) for Acetavance, the company's intravenous formulation of acetaminophen for the treatment of acute pain and fever in adults and children. As previously reported, both the Sinatra Study and Study 302 have already been completed with positive outcomes. Cadence is not required nor does it currently plan to initiate any additional clinical trials of Acetavance for NDA submission.

Upon the completion of ongoing clinical trials evaluating pediatric pharmacokinetics (Study 102), adult safety (Study 351), and pediatric safety (Study 352), the clinical development plan, consistent with the advice received from the FDA, will be complete. The company's abdominal laparoscopic surgery trial (Study 304) is not required for submission of the Acetavance NDA. The company currently anticipates submitting the NDA in the second quarter of 2009.

"We are very pleased with the outcome of our communications with the FDA," stated Ted Schroeder, President and Chief Executive Officer of Cadence. "With this clear guidance, we can now focus on completing the ongoing development activities and preparing to submit the Acetavance NDA."

Conference Call and Webcast on July 30, 2008 at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time)

Cadence management will host a conference call on July 30, 2008 at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time). Interested investors may participate in the conference call by dialing 877-419-6590 (domestic) or 719-325-4861 (international). To access the webcast, please visit the company's website at http://www.cadencepharm.com/ [1] and go to the Investor Relations page. A replay of the webcast will be available on the company's website approximately two hours after the call.

About Acetavance

Acetavance is a proprietary intravenous formulation of acetaminophen for the treatment of acute pain and fever. Cadence acquired the exclusive rights to Acetavance in the United States and Canada from Bristol-Myers Squibb Company (BMS), which has marketed the product as Perfalgan throughout Europe and other parts of the world beginning in 2002. In 2007, BMS sold approximately 80 million units in Europe, where it is the market leading injectable analgesic in terms of both dollars and units sold. In the United States, injectable analgesics to treat acute pain, particularly in the post-operative setting, are currently limited to opioids and a single non- steroidal anti-inflammatory drug, both of which may be associated with significant adverse side-effects. In placebo-controlled clinical trials, Acetavance has demonstrated significant pain relief, improved patient satisfaction, and opioid-sparing potential with a safety profile comparable to placebo.

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 product candidates in development, Acetavance (intravenous acetaminophen) for the treatment of acute pain and fever, and Omigard (omiganan pentahydrochloride 1% topical gel) for the prevention of catheter-related infections. For more information about Cadence's pipeline, visit http://www.cadencepharm.com/ [2].