Salix Pharma/Positive Phase III Trial for Basalazide

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Salix Pharma Reports Promising Results From Phase III Registration

Trial For Balsalazide Tablets

Monday, June 18, 2007; Posted: 12:43 PM

(RTTNews) - Salix Pharmaceuticals Ltd. on Monday announced promising

results from its Phase III registration trial of a new 1100 mg tablet

formulation of balsalazide disodium or balsalazide tablets. The

company also said it currently anticipates to file its NDA for

balsalazide tablets by July 31, 2007.

The phase III registration trial is designed to assess the safety and

efficacy of a new 1100 mg tablet formulation of balsalazide disodium.

The company noted that a statistically significant greater proportion

of subjects dosed twice daily with balsalazide tablets for eight

weeks achieved clinical improvement, when compared to subjects

receiving placebo.

The distinction in response between balsalazide and placebo was

observed for both the primary efficacy endpoint as well as the key

secondary efficacy endpoints.

Balsalazide disodium is the active ingredient in Colazal Capsules 750

mg, an anti-inflammatory drug approved for the treatment of mildly to

moderately active ulcerative colitis. The drug was well tolerated in

clinical studies.

The most frequent adverse events were headache, abdominal pain,

diarrhea, nausea, vomiting, respiratory infection and arthralgia.

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