POSTER #65

Tolperisone 100 and 200 mg Three Times Daily (TID) for Acute Muscle Spasm of the Back: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase 3 Study

Authors:

Randall Kaye, MD; Henry Riordan, PhD; Srinivas Nalamachu, MD; Joseph Pergolizzi, MD; Sanam Ara Vaughan

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Key Highlights: Approximately 750 subjects are planned to be enrolled at about 60 clinical sites in the United States, with the first subject expected to be enrolled in Fall 2020. A second replicate Phase 3 study will be initiated at a later date.

ARTICLE

Novel Form of Muscle Relaxant Shows Benefit

Tolperisone may help pain from acute back spasms without causing drowsiness

Authors:

Judy George, Senior Staff Writer, MedPage Today September 5, 2020

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Key Highlights: Tolperisone, a centrally-acting muscle relaxant, may treat symptoms of acute muscle spasms without the sleepiness and cognitive effects associated with other skeletal muscle relaxants.

POSTER #75

Tolperisone for Acute Muscle Spasm: Dose-Ranging STAR Study

Authors:

Srinivas Nalamachu, MD; Randall Kaye, MD; Joseph Pergolizzi, MD

Key Highlights: Tolperisone dose of 200 mg TID may be a promising treatment for the management of acute muscle spasm without the somnolence typically experienced with skeletal muscle relaxants.

PUBLICATION

DRIVING STUDY

An assessment of the centrally acting muscle relaxant tolperisone on driving ability and cognitive effects compared to placebo and cyclobenzaprine

Authors:

Judy Caron PhD; Randall Kaye MD; Thomas Wessel MD, PhD; Amy Halseth PhD; Gary Kay PhD

What is new and conclusion: Subjects who received tolperisone (150 mg TID) experienced no impact on various measures of driving, self-reported sleepiness and cognition measures compared to placebo, in contrast to those who received the widely used muscle relaxant cyclobenzaprine (10 mg TID).