Pacira ((PCRX)) announced an update on their ongoing clinical study.
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Study Overview: Pacira Pharmaceuticals is conducting a multicenter, randomized, double-blind, sham-controlled study titled ‘A Multicenter, Randomized, Double-Blind, Sham-Controlled Study Assessing the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity.’ The study aims to evaluate the efficacy and safety of the iovera° system in treating upper extremity spasticity, a condition often associated with cerebral or spinal issues. This study is significant as it could offer a new treatment option for patients suffering from this debilitating condition.
Intervention/Treatment: The study tests the iovera° system, a device designed to treat upper extremity spasticity. Participants will receive either the active iovera° system treatment or a sham treatment, both administered using ultrasound guidance.
Study Design: This Phase 3 interventional study employs a randomized, parallel assignment model with triple masking (participant, care provider, investigator) to ensure unbiased results. The primary purpose is treatment, focusing on the effectiveness and safety of the iovera° system.
Study Timeline: The study began on March 25, 2024, with the latest update submitted on May 14, 2025. These dates are crucial as they mark the study’s progress and ensure transparency in its development.
Market Implications: The ongoing study could significantly impact Pacira’s stock performance and investor sentiment, especially if the results demonstrate the iovera° system’s efficacy and safety. Successful outcomes may position Pacira favorably against competitors in the spasticity treatment market, potentially increasing its market share.
The study is currently recruiting, with further details available on the ClinicalTrials portal.