Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.

Inclusion Criteria:

- Healthy, ambulatory, male and female volunteers between 16 to 45

- Scheduled to undergo surgical removal of 1 - 2 impacted third molars, one of which
must be at least a partial mandibular bony impaction

- No use of any analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, any
other pain reliever (Over The Counter or prescription), or herbal supplements within
5 days of surgery

- Have moderate to severe postoperative pain on the Categorical Pain Intensity Scale (a
score of at least 2 on a 4 point scale) and a score of >/= 50 mm on the 100-mm visual
analog Pain Severity Rating Scale

Exclusion Criteria:

- History of hypersensitivity to naproxen sodium, aspirin (ASA), other NSAIDs, opioid
analgesics, and similar pharmacological agents or components of the investigational
products, including the placebo

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic
diseases, or malignancies

- Relevant concomitant disease such as asthma (exercise induced asthma is permitted),
chronic sinusitis or nasal structural abnormalities causing greater than 50 percent
obstruction (polyposis nasi, marked septal deviation) that can interfere with the
conduct of the study

- Current or past history of bleeding disorder(s)

- History of gastrointestinal bleeding or perforation, related to previous NSAID
therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more
distinct episodes of proven ulceration or bleeding)