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     303  0 Kommentare Revance Highlights Recent Regulatory Progress and Provides Anticipated 2019 Milestones - Seite 3

    Phase 2 Trial for Treatment of Plantar Fasciitis – Trial initiated, with first patient dosed at end of 2018

    Revance has initiated patient dosing in a Phase 2 clinical trial for RT002 for the management of plantar fasciitis. The plantar fascia is the foot’s shock absorber. Repeated pressure on this tissue, whether from sport activities, aging, or obesity, can result in plantar fasciitis, characterized by inflammation accompanied by sharp, constant pain in the heel that can become highly debilitating. There are currently no FDA-approved drugs to treat plantar fasciitis. Estimates suggest that 20 million people suffer from plantar fasciitis in the U.S. annually and more than two million patients per year receive treatment. Revance expects to complete enrollment in this Phase 2 trial during the second half of 2019.

    Trial Design - The Phase 2 prospective, randomized, double-blind, multi-center, placebo-controlled study will evaluate the safety and efficacy of two doses of administration of Revance’s investigational drug candidate DaxibotulinumtoxinA for Injection (RT002) in reducing the signs and symptoms of plantar fasciitis. The study is expected to enroll approximately 150 adult patients with unilateral plantar fasciitis, from approximately 20 study centers in the United States. Patients will be randomized (1:1:1) to receive an injection of a low dose, high dose or placebo. The study’s primary efficacy endpoint is the change from baseline in Numeric Pain Rating Scale (NPRS) score at Week 8. Patients will be followed for up to 24 weeks post treatment to assess treatment response, tolerability and safety.

    Additional information, including patient eligibility criteria, will be posted shortly at www.clinicaltrials.gov.

    JUNIPER Phase 2 Trial for Treatment of Adult Upper Limb Spasticity–Trial now underway, with first patient dosed in late December 2018

    Today, Revance announced it dosed the first patient in the JUNIPER Phase 2 clinical trial for RT002 in the treatment of upper limb spasticity. Upper limb spasticity is a form of movement disorder that presents as increased tone or stiffness of the muscles affecting a patient’s ability to produce or control voluntary movement in the arms and hands. Treatment using neuromodulators for upper limb spasticity was estimated in 2017 to be more than a $200 million global opportunity, with the muscle movement market exceeding $1 billion globally. The company expects to complete enrollment in the second half of 2019.

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    Revance Highlights Recent Regulatory Progress and Provides Anticipated 2019 Milestones - Seite 3 Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing next-generation neuromodulators for use in treating aesthetic and therapeutic conditions, today announced updates on meetings with the U.S. Food and …