Allergan’s planning to keep the label expansions coming for blockbuster Botox, which already boasts a range of indications in both the therapeutic and aesthetic spheres. And the company is eyeing depression as the product’s next frontier.
The Dublin drugmaker is wrapping up a phase 2 study of its star, based on investigator-initiated trials done in Germany that showed a single administration of Botox could match other antidepressants from an efficacy standpoint. Allergan anticipates getting its hands on the data at some point next year, and if it can replicate the German findings, “it’s going to be really valuable in psychotherapy, no doubt,” company R&D chief David Nicholson told FiercePharma in an interview.
The reason? There’s “a big need for different treatment modalities in depression,” a condition that affects millions of Americans, he said, pointing out that “any given antidepressant is effective in perhaps one-third of the patients who receive it.” Doctors generally switch patients between medications trying to find one that works, but even when it does, “after a period of time, the antidepressant that is working is no longer effective,” Nicholson noted.
Of course, there are some obvious differences between Botox and the meds that are currently out there—including Botox’s status as an injectable, rather than an oral therapy. But while patients tend to prefer pills—and psychiatrists aren’t quite used to giving injections—Nicholson doesn’t see administration as a hurdle.
“We will need to educate the psychiatric community,” he acknowledged, but if Botox can prove its worth, “I have no doubt in my mind the psychiatric community will embrace it and will start giving in injections,” he said.
There’s precedence for that optimism where Botox is concerned. Nicholson pointed to chronic migraine, an area where Botox has recently made a splash. “The efficacy of Botox in treating chronic migraine is so remarkable that we initiated a training program that has been embraced by neurologists and physicians in headache clinics who were also not used to giving injections,” he said.
Botox, Allergan's leading drug with $1.98 billion in 2015 sales, already boasts 11 indications and has provided a “pipeline in a drug” for Allergan for years. And while many people associate the brand with wrinkles and crow’s feet, sales are “somewhat greater” for therapeutic uses—such as chronic migraine, overactive bladder and muscle spasticity—than they are for aesthetics, Nicholson said.
Allergan isn’t relying solely on Botox to help it penetrate the depression space, though. It’s also got a phase 3 compound, injectable rapastinel, in its pipeline, with an oral follow-up earlier on in development.