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Allergan Gets Canadian Approval for Botox

April 06, 2001|Dow Jones and Reuters

Irvine eye- and skin-care company Allergan Inc. said Thursday that Canadian regulators have approved the use of its neurological drug Botox as a treatment to reduce prominent lines on a person's brow.

The company said in a press release that the approval for cosmetic use is the first from Phase 3 clinical trials of the drug.

Results from the latest phase found that after 30 days, 84% of patients using Botox reported a significant reduction in the severity of glabellar lines, or furrowed brow, that appeared in the face while frowning. In addition, 90% reported a significant change in their overall appearance.

Only 1.6% of patients in the placebo-controlled group reported similar results. Headaches, reported in 12.5% of patients, were the most common side effect.

The study's 264 patients were men and women age 23 to 76.

In January, Allergan filed for regulatory approval to use Botox to treat glabellar lines in the United States. It has U.S. approval to use the drug to treat cervical dystonia, a movement disorder characterized by involuntary muscle contractions.

Allergan stock gained $3.60 a share Thursday to close at $75.30 on the New York Stock Exchange.

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