AbbVie Reports Positive Phase 2 Results For BOTOX® In Essential Tremor Study

AbbVie, announced positive topline results from its Phase 2 ELATE trial, which evaluated the safety and efficacy of onabotulinumtoxinA (BOTOX®) versus placebo in patients with upper limb essential tremor.

The trial met its primary endpoint, showing a statistically significant improvement in Tremor Disability Scale-Revised (TREDS-R) scores at week 18 for patients treated with BOTOX® compared to placebo. Specifically, the onabotulinumtoxinA group demonstrated a greater reduction in unilateral TREDS-R total scores (-2.61 vs. -1.61; p=0.029). The treatment also achieved all six secondary endpoints, reinforcing its potential therapeutic benefit for tremor management.

"Essential tremor is a progressive neurological condition that affects millions worldwide and often results in unsatisfactory outcomes with current treatments. No new pharmacological treatments have been approved in the U.S. for essential tremor for more than 30 years. These results represent a significant advance and demonstrate further proof of mechanism for a neurotoxin as a potential treatment option to help patients and healthcare providers manage this challenging condition," said Daniel Mikol, M.D., Ph.D., vice president, neuroscience development, AbbVie. 

The safety profile was consistent with known data for onabotulinumtoxinA. Muscular weakness was the most common adverse event, occurring in 24.5% of treated patients versus 2.3% in the placebo group, with events described as localized, transient, and mostly mild to moderate in severity. AbbVie emphasized that the use of BOTOX® for essential tremor is not yet approved by the U.S. FDA or other regulatory authorities, and its safety and efficacy remain under evaluation.