MARCH 2021

McMahon Group

PMN Interview with Dr. Randall Kaye, CMO

Tolperisone, a skeletal muscle relaxant, was first developed in the mid-20th century in eastern Europe, and has been used throughout the globe since—except in the U.S. Randall Kaye, Chief Medical Officer, Neurana Pharmaceuticals talks about his company's journey in bringing tolperisone to the U.S. market, specifically on research presented at PAIN Week 2020.


JUNE 25, 2021


The Effects of Tolperisone on Simulated Driving Performance, Drowsiness, and Cognitive Function: Comparison With Cyclobenzaprine and Placebo in a Phase 1, Randomized, 4-Period Crossover Study


Gary Kay, PhD Sanam Ara Vaughan, Nathan Cashdollar, PhD, Randall Kaye

Key Highlights: Effects of tolperisone on driving performance, self-reported sleepiness, cognitive function, and rates of somnolence were comparable to subjects who received placebo. In addition, subjects on cyclobenzaprine indicated that they are “Ready to Drive”; however, the data as demonstrated by SDLP and lane exceedance, indicated that subjects are, in fact, not fine to drive and pose a driving risk.


SEP 11-13, 2020


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.


FEB 3, 2020




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).

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JAN 2021


Acute Muscle Spasms of the Back

Overview of Muscle Spasm Clinical Features & Presentation

Key Highlights: Acute muscle spasms of the back are sudden, sustained involuntary contractions of muscles or muscle groups localized within the spine. During a lifetime, approximately 84% of US adults (175 million) experience musculoskeletal spasms. A review of muscle spasms and clinical features and presentation. 


SEP 11-13, 2020


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.

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NOV 24, 2020


Tolperisone for the Treatment of Acute Muscle Spasm of the Back: Results From the Dose-Ranging Phase 2 STAR Study (NCT03802565)


Srinivas Nalamachu, Joseph Pergolizzi, Randall Kaye, MD

Key Highlights: Tolperisone 200 mg TID may be a promising treatment for management of acute muscle spasm, without the somnolence typically associated with SMRs. 


SEP 5, 2020


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.