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Botox Relieves Pain Caused by Migraines

Posted on: Thursday, 11 September 2008, 16:00 CDT

Allergan Inc reported Thursday that its product Botox is helpful for patients suffering from chronic migraines.

Botox, or botulinum toxin type A, is commonly used as a cosmetic treatment to smooth out unwanted wrinkles.

An estimated 1.2 million to 3.6 million people in the U.S. suffer from chronic migraines, Allergan said.

The company said data from its Phase III clinical trials showed a significantly greater decrease in headache days among patients who received Botox compared to those who received a placebo.

Shares of Allergan, which had been under pressure amid concerns the trial would fail, rallied as much as 13 percent as the broad market stumbled.

"This is positive, there's no question about it," said Jefferies & Co analyst Peter Bye. "The question is, how positive? The devil is in the details here."

The first Phase III trial missed its primary goal of a reduction in the number of headache episodes compared with placebo, but did demonstrate a statistically significant benefit on the secondary goal of a reduction in headache days versus placebo.

Allergan changed its primary goal of reducing the number of headache episodes to headache days based on the fact that the U.S. Food and Drug Administration preferred to gauge headache days.

In the second Phase III study, the primary goal and secondary goal showed a statistically significant benefit for Botox over placebo.

"At this point, it is unclear to us if Allergan will be successful in obtaining a headache indication as we cannot think of a drug that received an indication after missing the primary endpoint in one study and switching the primary endpoint in the second study," Wachovia analyst Larry Biegelsen wrote in a research note.

He said he expects the FDA to conduct an Advisory Committee meeting, which could be to Allergan's advantage since Botox appears to be effective in treating migraine.

"However, without seeing the actual clinical data, it is unclear to us if the results were clinically relevant," he said.

Without an indication, the company could not promote the data as the U.S. Department of Justice is already investigating the off-label promotion of Botox for migraine, Biegelsen noted.

In March, Allergan said it received a subpoena from the Justice Department investigating the promotion of Botox. The company said it believes the subpoena is related to alleged off-label promotion of Botox to treat headaches, for which it is not approved.

Even so, it’s likely that some physicians will try Botox in patients who suffer from hard to manage migraines, Bye said, noting that Botox costs about $530 a vial, and more than one vial is used to treat a headache.

Allergan said it hopes to file a supplemental biologics license application with the FDA for the use of Botox in chronic migraine by mid-2009.=

The company expects full data results to be published or presented by mid-2009.

"If the data were really good and clean, I doubt (Allergan) would be waiting until mid-2009 to file (its FDA application)," Bye said.

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• Allergan Inc

Source: redOrbit Staff & Wire Reports

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