Allergan, the manufacturer of Botox and the successful eye treatment Restatis, is no longer the industry leader it once was. Most experts agree that, when administered by a licensed professional, Botox is safe in small doses. Allergan claims that the benefits and risks of toxins are well known. In 2002, the FDA approved Botox for expression lines (wrinkles between the eyebrows), making it the first pharmaceutical drug to be given the green light for a strictly cosmetic purpose.
European doctors were intrigued when they noticed that their patients who received Botox for facial spasms were sweating less than usual. This wouldn't change anything for doctors, as they can already prescribe it off-label, and some do with great results. But it would allow Allergan to start marketing Botox for depression, which could significantly increase its adoption and sales. Even if the laws remain unchanged, doctors are expected to continue to explore the boundaries of Botox applications, sometimes with remarkable results.
Both Chapman and Bomba-Warczak believe that Botox is safe when used correctly, but they say their inboxes quickly filled with messages after their study was published. Six weeks later, 52% of people who received Botox reported a decrease in 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 may not be aware of the black box warning, doctors have a responsibility to explain 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.
Drug manufacturers are often aware of unapproved uses long before they are officially recognized by the FDA; this is 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 as a treatment for depression.