As a long-time leader in neuroscience, Jazz has held a longstanding commitment to provide therapies and support for patients living with serious, debilitating neurologic disorders, to help them reclaim their lives. Even though essential tremor (ET) is considered the most common movement disorder, affecting millions of people worldwide,1 there are limited treatment options for patients.
People living with ET experience an abnormal and involuntary rhythmic shaking (tremor) that most commonly affects the hands and arms, but tremor can also occur in the head, voice, and lower limbs. As a result of this serious condition, people living with ET can struggle to perform daily activities (e.g., eating, dressing, and personal hygiene) and function socially.
The first and only approved FDA-approved medicine for the treatment of ET was approved over 50 years ago.2 It is estimated that up to half of patients do not respond to first-line therapy, and over 50% of patients reportedly discontinue medication due to lack of efficacy and/or side effects.3,4 There is a clear and urgent need for new treatment options for patients with ET, and we believe developing medicines that can improve the day-to-day functioning of patients with ET aligns with our mission to provide life-changing medicines.
Jazz is currently investigating a potential new therapy, a highly selective modulator of T-type calcium channels, for the treatment of moderate to severe ET. Many neurologic disorders, including ET, are characterized by abnormal rhythms in certain regions of the brain mediated by T-type calcium channels, which are important for controlling movement.5,6 The mechanism through which our investigational therapy is thought to improve tremor in patients with ET is unique from all currently utilized medicines for patients with ET and may thus represent a meaningful advancement in the treatment of the condition.7
Our investigational treatment has already been evaluated in a Phase 2a randomized, placebo-controlled clinical study in adults with ET. Results of that study provided proof-of-concept data to support it as a promising candidate for ET and have recently been published in the peer-reviewed journal Movement Disorders.8
As a next step in development, Jazz is conducting a follow-up Phase 2b clinical study (the EveresT study) that will evaluate adults with moderate to severe ET treated with a once-daily oral formulation. The study is being conducted by doctors in the U.S., Germany, Poland, and Spain. The outcome measures used are focused on assessing changes in day-to-day functioning due to tremor. Additional information about the trial can be found here.
Notably, Jazz is also conducting a Phase 2 clinical study to evaluate efficacy and safety of the once-daily formulation in the treatment of moderate to severe residual tremor in patients with Parkinson’s disease (PD), the second most common neurodegenerative disease affecting nearly 1 million people in the United States and more than 6 million people worldwide. Tremor is one of the most prominent and visible features of PD and is often the first symptom noticed by patients; however, there are currently no pharmacotherapies specifically approved for the treatment of tremor in patients with PD. Learn more about the study here.
We are proud to build on our expertise in neuroscience to develop this investigational candidate for people living with ET and PD who currently have limited treatment options.
