Meet the new Botox: The one that’s injected 30 times directly into your bladder.
As Irvine, Calif., Botox-maker Allergan slashes jobs, in part over slumping cosmetic sales of the beneficial toxin, it continues with clinical trials that would expand the drug’s therapeutic uses. You may not know from its Nip/Tuckimage, but half of Botox’s revenues come from medical treatments that go well beyond smoothing wrinkly foreheads.
Allergan hopes this year to win U.S. Food and Drug Administrationapproval for a Botox treatment to help muscle-tightening problems in stroke victims. The company is in various phases of clinical trials for applications that treat chronic migraines, overactive bladder and prostate problems.
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“In addition, we are now exploring novel next-generation molecules that could open up a new approach to ‘personalized medicine,’ ” said Caroline Van Hove, Allergan’s vice president of corporate communications.
Last year didn’t end well for Allergan. The company’s sales slumped in the fourth quarter, and it announced it would cut 460 jobs — about 5 percent of its workforce.
While Allergan sold more Botox in 2008 than the previous year, sales of the drug tumbled at year’s end — coming in less than $10 million compared to the previous fourth quarter.
Plus, Allergan predicts a decline in Botox sales in 2009 — from $1.31 billion this year down to as little as $1.15 billion.
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What’s in the pipeine? Two clinical trials, which are taking place, in part at the Cleveland Clinic, provide a window into the potential for the new Botox.The Clinic’s Glickman Urological and Kidney Institute is participating in a Phase III trial treating neurogenic – or nerve-related – overactive bladder as well as a Phase II trial focusing on idiopathic overactive bladder.
The hope is that Botox will be an option for patients who do not respond to medications. “It’s a far cry from being a first-line therapy,” said Dr. Courtenay Moore, a Cleveland Clinic physician working on the trials.
The Clinic performs about 75 Botox-related procedures a year. Since the procedure isn’t approved by the FDA, there’s no reimbursement from Medicare or private insurance.
Most of the time, the 300 units of Botox needed for the procedure cost $900. Many of the patients fill their Botox prescription from online pharmacies who sell the drug for lower prices, Moore said.
But if the treatment is approved – and wins reimbursement – there’s a much broader potential for patients, Botox and health-care providers. About one-third of the 33 million Americans who have overactive bladder problems aren’t helped by FDA-approved therapies, and at least 60 percent of patients have side effects to overactive-bladder drugs.
There’s little question the Botox procedures work. Much of the focus now is on how it can work best and whether it is possible to manage a few notable, potential side effects.
Currently, the 10-minute outpatient procedure – in which the patient remains conscious – involves 30 injections of Botox into the bladder muscle. The treatment usually lasts between 8 months to a year.
Moore said the primary question confronting physicians performing the procedures is how much Botox is enough, and what’s the propert volume of Botox at each injection site. “We don’t know these answers,” Moore said.
Some research suggests the 300 units may be necessary as a maximum dose, but that other patients could get by on as little as 100 units.
Solving dosage problems may address some of the side effects. About 10 percent of patients Moore worked with have a small amount blood in their urine afterward.
Plus, researchers are worried about reflux — that urine from the bladder could go back into the kidney — if Botox is injected into the trigone area of the bladder near the urethra. “That is a theoretical concern,” Moore said.
About 10 to 20 percent of patients who get the treatment aren’t able to urinate after the procedure and require a temporary catheter.
“We’re still investigating why it happens in certain populations,” Moore said. “Is it the placement of the injection? Is it the amount? Why does it happen in some people and in others, it doesn’t?”
