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Praxis Drug Shows Strong Results in Essential Tremor Trials

Praxis Drug Shows Strong Results in Essential Tremor Trials

Praxis Precision Medicines' ulixacaltamide achieves significant clinical results in two Phase 3 studies for essential tremor, offering hope for millions.

Laboratory researchers conducting clinical studies for Praxis Medicines' Essential3 trial focused on essential tremor.

Source:

Praxis Medicines

Breakthrough Results for Essential Tremor Drug

Praxis Precision Medicines announced that its investigational drug ulixacaltamide met all primary and key secondary endpoints in two pivotal Phase 3 studies for essential tremor (ET). The trials, part of the Essential3 program, enrolled 473 adults and used a decentralized model with in-home and telehealth visits [BioPharma Dive].

Study Approach

  • Randomized, placebo-controlled, 12-week trials

  • Patient-centric design using validated daily living questionnaires

  • Measured functional improvement in self-care and daily tasks

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Patient undergoing neurological examination as part of the Essential3 clinical trial.

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Getty Images

Key Findings From the Essential3 Trials

  • Ulixacaltamide provided a 4.3-point improvement in daily activities versus placebo at Week 8 (p<0.0001) [Applied Clinical Trials].

  • Benefits were sustained throughout the 12-week dosing period.

  • In the withdrawal part of the study, 55% of patients on the drug maintained response, compared to 33% on placebo.

Treatment Landscape

Essential tremor is the most common adult movement disorder, with limited treatments. The only current FDA-approved option, propranolol, has side effects like dizziness and fatigue and does not work for all [Neurology Journal].

Medical professionals reviewing brain scan results in neurology clinic for essential tremor clinical research.

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Shutterstock

Market and Patient Impact

Analysts call the results a "complete upside surprise," with projections of a 70% FDA approval chance and potential sales exceeding $2.5 billion annually. Praxis has requested a pre-NDA (New Drug Application) meeting with the FDA and aims to file in early 2026 [MedPath].

Community Reaction

  • The International Essential Tremor Foundation hailed the results as "an extraordinary step" for under-served patients.

  • Experts believe the therapy could redefine care and quality of life for those with ET.

More information and images can be found at the Praxis Essential3 Study Site.

Market and Patient Impact

Analysts call the results a "complete upside surprise," with projections of a 70% FDA approval chance and potential sales exceeding $2.5 billion annually. Praxis has requested a pre-NDA (New Drug Application) meeting with the FDA and aims to file in early 2026 [MedPath].

Community Reaction

  • The International Essential Tremor Foundation hailed the results as "an extraordinary step" for under-served patients.

  • Experts believe the therapy could redefine care and quality of life for those with ET.

More information and images can be found at the Praxis Essential3 Study Site.

What are the potential side effects of ulixacaltamide?

Detailed safety results have not yet been published, but no major safety concerns were highlighted in the Phase 3 announcements. Full side effect data are expected with regulatory filings.

What are the potential side effects of ulixacaltamide?

Detailed safety results have not yet been published, but no major safety concerns were highlighted in the Phase 3 announcements. Full side effect data are expected with regulatory filings.

What are the potential side effects of ulixacaltamide?

Detailed safety results have not yet been published, but no major safety concerns were highlighted in the Phase 3 announcements. Full side effect data are expected with regulatory filings.

How does ulixacaltamide compare to other treatments for essential tremor?

How does ulixacaltamide compare to other treatments for essential tremor?

How does ulixacaltamide compare to other treatments for essential tremor?

What was the patient feedback on the Essential3 study?

What was the patient feedback on the Essential3 study?

What was the patient feedback on the Essential3 study?

How long did it take to complete the Essential3 study?

How long did it take to complete the Essential3 study?

How long did it take to complete the Essential3 study?

What are the key endpoints measured in the Essential3 study?

What are the key endpoints measured in the Essential3 study?

What are the key endpoints measured in the Essential3 study?

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