Study Data Show That Investigational Injectable COX-2 Specific Inhibitor Reduced the Need for Narcotics in Treatment of Pain Following Surgery

- Parecoxib Sodium IV Reduced Morphine Consumption,

Improved Pain Relief in Study of Total Hip Replacement -



Apr 23, 2001, 01:00 ET from Pharmacia Corporation

    PHOENIX, April 23 /PRNewswire Interactive News Release/ -- Results from a
 Phase III, placebo controlled study presented this weekend at the American
 Pain Society (APS) 20th Annual Scientific Meeting showed that administration
 of parecoxib sodium, the first investigational injectable COX-2 specific
 analgesic, significantly reduced the amount of morphine consumed by patients
 following total hip replacement surgery while improving overall pain relief.
 In a separate study, a single dose of parecoxib sodium was shown to provide
 superior analgesia to a single dose of morphine in the control of pain
 following total knee replacement surgery.
     According to results of the 175-patient multicenter, randomized, double-
 blind study, patients receiving a 40 mg dose of parecoxib sodium required 39%
 less morphine in the 24 hours following hip replacement surgery compared with
 placebo-treated patients.  Patients were randomly assigned to receive
 parecoxib sodium 20 mg (n=60), parecoxib sodium 40 mg (n=53), or placebo
 (n=62). Although the overall incidence of adverse events was similar between
 groups, significantly fewer patients in the parecoxib sodium 40 mg group
 reported fever and/or vomiting than did those in the placebo group.  These
 patients also scored significantly higher in Pain Intensity Difference scores
 at most or all assessment points, as well as in measures of overall well-
 being.
     "Surgical pain management all too often requires a compromise between
 achieving maximum pain control and minimizing side effects," said Dr. T.
 Philip Malan, Associate Chair for Research in the Department for
 Anesthesiology at the University of Arizona Health Science Center, and the
 study's principal investigator.  "An agent that could reduce both the need for
 opioids and improve overall pain relief would be an exciting step toward
 better acute pain management."
     With more than 160,000 procedures performed every year in the U.S., total
 hip replacement is the second most common joint replacement surgery after
 total knee replacement (more than 250,000 procedures).  The reason most people
 undergo these surgeries is to relieve chronic pain caused by osteoarthritis
 and allied disorders.
 
     Control of Pain in Total Knee Replacement Study
     In a second Phase III, multicenter, double-blind study presented at the
 APS Meeting, the control of pain following total knee replacement was
 evaluated in 208 patients using single IV doses of parecoxib sodium, morphine,
 or ketorolac, a traditional nonsteroidal anti-inflammatory drug.
     Parecoxib sodium 40 mg provided analgesic efficacy comparable to ketorolac
 30 mg and superior to morphine 4 mg at most time points.  In addition, 80
 percent of patients who received the 40 mg dose of parecoxib sodium rated
 their pain medication as good or excellent, compared with approximately 70
 percent of ketorolac patients, and 45 percent of morphine patients.
     "Managing pain following knee replacement surgery can be challenging,
 particularly when faced with some of the shortcomings of currently available
 analgesics," said Dr. G. Lynn Rasmussen, Medical Staff President at The
 Orthopedic Specialty Hospital, Utah, and the lead investigator for the knee
 replacement study.  "This study suggests that parecoxib may become an
 effective and well-tolerated treatment option."
 
     The Need for New Injectable Analgesics
     Recent studies have shown that more than 70% of patients who undergo
 surgery experience moderate to extreme post-operative pain.  Several factors
 may contribute to inadequate post-operative pain management, including the
 shortcomings of current injectable pain medications.
     Opioids like morphine are widely used for the management of post-operative
 pain, either alone or in combination with other types of analgesics.  The
 effectiveness of opioids alone is often limited by side effects such as
 sedation, nausea, constipation, vomiting, and respiratory depression-all of
 which can become more severe with increasing doses.  For orthopedic surgeries
 and other painful procedures, efforts to minimize the risk of adverse events
 often leads to the administration of opioid doses that do not completely
 relieve post-surgical pain.  Combining opioid and non-opioid analgesics offers
 several potential benefits, including reduced opioid dose requirements, fewer
 and less severe side effects, and improved control of pain.
     Injectable analgesics are favored in the perioperative setting because
 they have a rapid and reliable onset of effect.  In the U.S., injectable
 analgesic options are limited to opioids and one NSAID, ketorolac.  Ketorolac
 is associated with side effects that may limit its use in the perioperative
 setting.  Most importantly, it inhibits blood clotting, and therefore cannot
 be administered pre-operatively.  Gastrointestinal side effects (e.g.,
 ulceration) may also limit the post-operative use of the drug.
     Parecoxib sodium is the first investigational injectable COX-2 specific
 inhibitor.  Like other COX-2 specific inhibitors, it is believed to reduce
 pain and inflammation by targeting the cyclooxygenase (COX)-2 enzyme, which
 becomes activated at sites of injury, including surgical incisions.  At
 therapeutic doses, parecoxib sodium does not affect COX-1, which plays an
 important role in regulating normal cell function in the blood and stomach.
 
     The studies were funded by Pharmacia Corporation (NYSE:   PHA), a leading
 global pharmaceutical company created through the merger of Pharmacia & Upjohn
 with Monsanto Company and its G.D. Searle unit.  Pharmacia has a broad product
 portfolio, a robust pipeline of new medicines, and an annual investment of
 more than $2 billion in pharmaceutical research and development.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X57675181
 
 

SOURCE Pharmacia Corporation
    PHOENIX, April 23 /PRNewswire Interactive News Release/ -- Results from a
 Phase III, placebo controlled study presented this weekend at the American
 Pain Society (APS) 20th Annual Scientific Meeting showed that administration
 of parecoxib sodium, the first investigational injectable COX-2 specific
 analgesic, significantly reduced the amount of morphine consumed by patients
 following total hip replacement surgery while improving overall pain relief.
 In a separate study, a single dose of parecoxib sodium was shown to provide
 superior analgesia to a single dose of morphine in the control of pain
 following total knee replacement surgery.
     According to results of the 175-patient multicenter, randomized, double-
 blind study, patients receiving a 40 mg dose of parecoxib sodium required 39%
 less morphine in the 24 hours following hip replacement surgery compared with
 placebo-treated patients.  Patients were randomly assigned to receive
 parecoxib sodium 20 mg (n=60), parecoxib sodium 40 mg (n=53), or placebo
 (n=62). Although the overall incidence of adverse events was similar between
 groups, significantly fewer patients in the parecoxib sodium 40 mg group
 reported fever and/or vomiting than did those in the placebo group.  These
 patients also scored significantly higher in Pain Intensity Difference scores
 at most or all assessment points, as well as in measures of overall well-
 being.
     "Surgical pain management all too often requires a compromise between
 achieving maximum pain control and minimizing side effects," said Dr. T.
 Philip Malan, Associate Chair for Research in the Department for
 Anesthesiology at the University of Arizona Health Science Center, and the
 study's principal investigator.  "An agent that could reduce both the need for
 opioids and improve overall pain relief would be an exciting step toward
 better acute pain management."
     With more than 160,000 procedures performed every year in the U.S., total
 hip replacement is the second most common joint replacement surgery after
 total knee replacement (more than 250,000 procedures).  The reason most people
 undergo these surgeries is to relieve chronic pain caused by osteoarthritis
 and allied disorders.
 
     Control of Pain in Total Knee Replacement Study
     In a second Phase III, multicenter, double-blind study presented at the
 APS Meeting, the control of pain following total knee replacement was
 evaluated in 208 patients using single IV doses of parecoxib sodium, morphine,
 or ketorolac, a traditional nonsteroidal anti-inflammatory drug.
     Parecoxib sodium 40 mg provided analgesic efficacy comparable to ketorolac
 30 mg and superior to morphine 4 mg at most time points.  In addition, 80
 percent of patients who received the 40 mg dose of parecoxib sodium rated
 their pain medication as good or excellent, compared with approximately 70
 percent of ketorolac patients, and 45 percent of morphine patients.
     "Managing pain following knee replacement surgery can be challenging,
 particularly when faced with some of the shortcomings of currently available
 analgesics," said Dr. G. Lynn Rasmussen, Medical Staff President at The
 Orthopedic Specialty Hospital, Utah, and the lead investigator for the knee
 replacement study.  "This study suggests that parecoxib may become an
 effective and well-tolerated treatment option."
 
     The Need for New Injectable Analgesics
     Recent studies have shown that more than 70% of patients who undergo
 surgery experience moderate to extreme post-operative pain.  Several factors
 may contribute to inadequate post-operative pain management, including the
 shortcomings of current injectable pain medications.
     Opioids like morphine are widely used for the management of post-operative
 pain, either alone or in combination with other types of analgesics.  The
 effectiveness of opioids alone is often limited by side effects such as
 sedation, nausea, constipation, vomiting, and respiratory depression-all of
 which can become more severe with increasing doses.  For orthopedic surgeries
 and other painful procedures, efforts to minimize the risk of adverse events
 often leads to the administration of opioid doses that do not completely
 relieve post-surgical pain.  Combining opioid and non-opioid analgesics offers
 several potential benefits, including reduced opioid dose requirements, fewer
 and less severe side effects, and improved control of pain.
     Injectable analgesics are favored in the perioperative setting because
 they have a rapid and reliable onset of effect.  In the U.S., injectable
 analgesic options are limited to opioids and one NSAID, ketorolac.  Ketorolac
 is associated with side effects that may limit its use in the perioperative
 setting.  Most importantly, it inhibits blood clotting, and therefore cannot
 be administered pre-operatively.  Gastrointestinal side effects (e.g.,
 ulceration) may also limit the post-operative use of the drug.
     Parecoxib sodium is the first investigational injectable COX-2 specific
 inhibitor.  Like other COX-2 specific inhibitors, it is believed to reduce
 pain and inflammation by targeting the cyclooxygenase (COX)-2 enzyme, which
 becomes activated at sites of injury, including surgical incisions.  At
 therapeutic doses, parecoxib sodium does not affect COX-1, which plays an
 important role in regulating normal cell function in the blood and stomach.
 
     The studies were funded by Pharmacia Corporation (NYSE:   PHA), a leading
 global pharmaceutical company created through the merger of Pharmacia & Upjohn
 with Monsanto Company and its G.D. Searle unit.  Pharmacia has a broad product
 portfolio, a robust pipeline of new medicines, and an annual investment of
 more than $2 billion in pharmaceutical research and development.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X57675181
 
 SOURCE  Pharmacia Corporation