Allergan asks FDA for lucrative new Botox indication

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Allergan ($AGN) is making its next play to inject more value into Botox. The company has asked U.S. and European regulators to approve its wrinkle-fighting injection to treat patients with garden-variety overactive bladder, citing two Phase III trials.

It's a much larger market than Botox's already approved use to fight incontinence in patients with neurological problems, such as multiple sclerosis. The company estimates that 3.2 million American use oral drugs to fight overactive bladder, and more than half of them stop taking the pills because they either don't work or cause troublesome side effects. Analysts have said the overactive-bladder use could add up to $400 million to Botox sales, which amounted to $1.6 billion last year.

The two studies found that Botox significantly decreased bladder leakage, compared with placebo, in patients who hadn't responded to the usual oral medications. The most common side effect was urinary tract infection, which cropped up in 15% to 20% of patients.

It's just the latest move by CEO David Pyott to push Botox further into the medical market. Now, about half of the drug's sales come from cosmetic use. The other half is an amalgamation of uses, including limb spasticity, migraine headaches and eye-muscle disorders. Next up? Allergan is developing Botox as a treatment for arthritis, a potential $4.4 billion boost to sales. It's also going for another cosmetic use: crow's feet, for an additional $100 million.

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