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Clinical Trials

Azulfidine EN-tabs Tablets (sulfasalazine delayed release tablets, USP)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved October 1996

Specific Treatments:

rheumatoid arthritis

General Information

Azulfidine EN-tabs have been approved for the treatment of rheumatoid arthritis (RA) in patients who have responded inadequately to or are intolerant of analgesics or other non-steroidal anti-inflammatory drugs (NSAIDs). Azulfidine EN-tabs are enteric-coated to reduce stomach absorption and minimize gastrointestinal irritation.

Available by prescription only, Azulfidine EN-tabs are administered daily in evenly divided doses (2-3) totaling two grams and are recommended for use in concurrent treatment with analgesics and/or other NSAIDs, at least until effects are apparent.

Clinical Results

In clinical trials, the effects of Azulfidine EN-tabs were measured by the degree of improvement in the number and extent of actively inflamed joints. Subject response to Azulfidine EN-tabs in clinical trials were observed in some subjects as early as four weeks after starting treatment, but 12 weeks may be required in some subjects before clinical benefit is noted.

Side Effects

The most common adverse reactions associated with Azulfidine EN-tabs are anorexia, headache, nausea, vomiting, gastric distress, and reversible low sperm count. These side effects occur in one-third of subjects. Additionally, skin rash was reported by 13% of subjects in RA trials. The medication is contraindicated in pediatric subjects under two years of age, subjects with intestinal or urinary obstruction, subjects with porphyria (group of disorders associated with a lack of porphyins) and subjects hypersensitive to sulfasalazine, its metabolites, sulfonamides or salicylates. Complete blood counts and urinalysis should be done frequently in subjects taking Azulfidine EN-tabs.

Additional Information

Rheumatoid arthritis, one of the more common forms of arthritis is a chronic, systemic, inflammatory autoimmune disorder of unknown etiology. RA causes inflammation in the lining of the joints and other internal organs; destruction of cartilage, bone, tendons, and ligaments can follow. It affects approximately 1% of the U.S. population (2.5 million).

Disease onset occurs most often between the ages of 40 and 60 with 91% of patients older than 40. More than 60% of RA patients are women. With Americans living longer, RA is an important medical condition that is growing in magnitude.

According to 1996 clinical guidelines issued by the American College of Rheumatology (ACR), subjects with active RA have a 70% probability of developing joint damage or erosions within two years of disease onset. While NSAIDs are a common first step in alleviating symptoms of RA, joint damage may occur and progress. Therefore, many subjects will require second-line therapy if response to salicylates and other non-steroidal anti-inflammatory drugs is inadequate.

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