September 11-13, 2020



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



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

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.


Poster #75: Tolperisone for Acute Muscle Spasm: Dose-Ranging STAR Study



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



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)


Publication: MEDPAGE TODAY


Novel Form of Muscle Relaxant Shows Benefit
— Tolperisone may help pain from acute back spasms without causing drowsiness



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


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, data from the phase II STAR trial suggested.