Allergan, the manufacturer of Botox and the successful eye treatment Restatis, is not the same industry leader it once was. Most of the experts I spoke to agree that, in small doses, Botox is safe when administered by a licensed professional, but not everyone agrees that its safety extends to all its new, unapproved uses. Allergan says that Botox is well established as a drug and that the benefits and risks of toxins are well known. In 2002, Botox obtained FDA approval for so-called expression lines (wrinkles between the eyebrows), marking the first time that a pharmaceutical drug was given the green light for a strictly cosmetic purpose.
Similarly, European doctors were intrigued when they realized that their patients who received Botox for facial spasms were sweating less than usual. That wouldn't change anything for doctors, of course, they can already prescribe it off-label, and some do, with excellent results, but it would allow Allergan to start marketing Botox for depression, a change that could dramatically increase its adoption and sales. But even if the laws remain unchanged, as long as the law allows unauthorized uses, doctors are expected to continue to push the boundaries of Botox applications, sometimes in the name of medical progress and sometimes with remarkable results. Both Chapman and Bomba-Warczak think that Botox is safe when used correctly, but they say that their inboxes quickly filled with messages after the publication of their study.
Six weeks later, 52% of people who received Botox experienced a decrease in reported symptoms, compared to 15% of people who received a placebo. In the Rosenthal and Finzi research, 74 people with major depressive disorder were randomly assigned to receive injections of Botox or a placebo. In doctors' offices, where patients do not normally see the box in which the vials are packed and therefore may not be aware of the black box warning, doctors have a responsibility to describe the potential risks of any patient who chooses to try Botox for any condition, approved or not by the FDA. Allergan sells a range of products, but has also struggled to diversify beyond its line of aesthetic drugs and Botox, which has generated billions of dollars with its expanded use beyond smoothing frown lines to treat migraines and other health conditions.
Brubaker found that about 70% of women treated with Botox reported an average of three leaks a day, compared to the average of five leaks a day at the start of the study. Those non-cosmetic revenues are likely to skyrocket over the next few years as doctors test Botox for even more off-label uses and as Allergan conducts its own studies. Mitchell Brin, senior vice president of drug development at Allergan and chief scientific officer of Botox. But drug manufacturers are also often aware of unapproved uses long before those uses were officially recognized by the FDA; after all, that's how Botox ended up being approved for wrinkles.
If their results are in line with those of Rosenthal and Finzi, it would be huge, paving the way for Botox to gain official approval of the drug as a treatment for depression.