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Phase 3, RESUME-1, clinical study of tolperisone for the relief of muscle spasm associated with acute, painful musculoskeletal conditions, failed to meet its primary and key secondary endpoints.
Lead Product(s): Tolperisone
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2022
Details:
Company completed its Phase 3 RESUME-1 Study of tolperisone for the relief of muscle spasm associated with acute, painful musculoskeletal conditions. The primary endpoint showed patient reported pain at day 14 due to acute back spasm.
Lead Product(s): Tolperisone
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2021
Details:
The scientific abstracts presented at both congresses demonstrate the potential benefit of tolperisone as a non-opioid, non-drowsy, non-central nervous system impairing skeletal muscle relaxant.
Lead Product(s): Tolperisone
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2021
Details:
The published clinical data demonstrates the potential benefit of tolperisone in the treatment of acute and painful muscle spasms. The data supports and strengthens a planned Phase 3 RESUME-1 study, for which Neurana will begin enrollment imminently.
Lead Product(s): Tolperisone
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2020
Details:
The presentation will highlight results from a double-blind, randomized, placebo-controlled, multicenter phase 3 study evaluating Tolperisone 100 and 200 mg Three Times Daily (TID) for acute muscle spasm of the back.
Lead Product(s): Tolperisone
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2020
Details:
The study is a randomized, 4-period, crossover study designed to investigate the effects of tolperisone on measures of drowsiness and cognitive function compared to cyclobenzaprine and placebo.
Lead Product(s): Tolperisone
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2020
Details:
The publication reports results from the Phase 1, threeway, randomized, blinded, three-period crossover study that evaluated cyclobenzaprine in neuromuscular conditions.
Lead Product(s): Tolperisone
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2020
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