Allergan to move into Phase III trials with depression drug that’s raising eyebrows

Botox (onabotulinumtoxinA), a treatment which made its name for its aesthetic potential in reducing facial wrinkles, is to be taken into Phase III trials in major depressive disorder (MDD).

This is despite the failure of a Phase II trial of Botox in moderate to severe MDD.

Ireland-incorporated drugmaker Allergan (NYSE: AGN) announced the results of this study this week. The efficacy, safety and tolerability of a single administration of two different doses of 30 or 50 units of Botox relative to placebo in women with MDD was evaluated over 24 weeks.

The trial missed its primary endpoint, which was to show that Botox could meaningfully reduce depression after six weeks compared with a placebo injection.

While the 30-unit dose did show some improvement in symptoms, a Financial Times article questioning Allergan’s move to take Botox into late-stage studies described the results as “not strong enough to be sure the findings were scientifically significant”.

Despite its widespread reputation as a wrinkle smoother, Botox in fact has as many as 11 separate therapeutic indications, treating conditions ranging from overactive bladder to chronic migraines.

David Nicholson, Allergan’s chief research and development officer, who spoke about Botox's potential in depression in January, is confident that it could soon be considered as an option for MDD.

“We are encouraged by these data and the potential impact on adults with MDD,” he said. “Given our in-depth and extensive clinical trial experience in CNS including depression, we plan to move forward and develop a phase III program for a potential new treatment option for patients.”



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