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Scilex Holding Company, a Sorrento Company, Announces That the FDA Has Granted Fast Track Designation for SP-103 (Lidocaine Topical System) 5.4%, Next Generation Triple Strength Formulation of.
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Scilex's three product candidates are SP-102 (injectable dexamethasone sodium phosphate viscous gel product containing 10 mg dexamethasone), or SEMDEXA™, a Phase 3, novel, viscous gel.
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We received our SP-103 Phase 2 top-line results in August 2023 and the trial achieved its objectives characterizing safety, tolerability and preliminary efficacy of SP-103 in acute low back pain.
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The Phase 2. Real-Time News, Market Data, and Stock Quotes for Life Science Stocks @ healthstockshub.com Scilex Announces the Completion of its SP-103 (lidocaine topical system) 5.4%, Triple Strength Formulation of ZTlido®, Phase 2 trial which achieved its objectives to Evaluate the Safety and Efficacy of SP-103 in Subjects with Moderate to.
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Phase 1 studies are to characterize the pharmacokinetic and safety profile of SP-104, and Scilex intends to initiate a Phase 2 study in the second half of 2022. If successful, we believe SP-104 can become a pivotal treatment for management of FM, which represents a large commercial opportunity with high unmet needs.
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SP-103 is a pharmacologically validated drug candidate and has the potential as a leading agent for the treatment of LBP without the limitations of current therapies, including the addictive.
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SP-103 is a pharmacologically validated drug candidate and has the potential as a leading agent for the treatment of LBP without the limitations of current therapies, including the addictive.
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Phase 1 Phase 2 Phase 3 NDA/MAA Filing Approved Milestones; ZTlido® (lidocaine topical system) 1.8%. SP-103. Lidocaine Topical System 5.4% (3X) (Chronic Neck Pain) Fast Track . 2Q 2023: Completed Phase II Trial. Scilex is planning to initiate Phase 2/3 trial for neck pain in 2024:
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SP-103 is a pharmacologically validated drug candidate and has the potential as a leading agent for the treatment of LBP without the limitations of current therapies, including the addictive.
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Scilex Holding has completed a Phase II study of SP-103 (lidocaine topical system) 5.4% for the treatment of acute lower back pain (LBP).. The aim of the multicentre, parallel group, placebo-controlled, double-blind, randomised study is to evaluate the tolerability and safety of SP-103 in subjects with moderate to severe acute LBP.
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A phase 1 clinical trial investigating the safety and tolerability of odronextamab in patients with CLL or NHL is ongoing (NCT02290951). In a phase 1/1b clinical trial (NCT02500407), patients with relapsed or refractory follicular lymphoma who received fixed-duration mosunetuzumab monotherapy had an ORR of 68% and a CR rate of 50%.