Novel muscle relaxant treats muscle spasm without causing sleepiness: STAR trial

USA: Tolperisone may be a promising treatment for the management of acute muscle spasms without causing sleepiness and cognitive effects as experienced with other skeletal muscle relaxants. These are the findings from the phase II STAR trial which were presented at the American Society of Interventional Pain Physicians (ASIPP) virtual meeting.

According to Randall Kaye, chief medical officer of Neurana Pharmaceuticals in San Diego, who presented the findings at the meeting, the patients with acute, painful back muscle spasms who received 200 mg of oral tolperisone three times a day versus placebo experienced a significant decrease in "right now" pain intensity without increasing sleepiness.

Currently, acute muscle spasms are treated with oral or topical drugs like NSAIDs and acetaminophen, and non-pharmacologic therapy (such as superficial heat compresses or physical therapy). These skeletal muscle relaxants despite being effective, have CNS adverse effects mainly sleepiness that limits their use. 

In the STAR trial, the researchers evaluated the safety and efficacy of four doses of tolperisone -- 50 mg, 100 mg, 150 mg, or 200 mg three times a day -- versus placebo. It included a total of 415 patients (aged 18-65 years) with acute back muscle spasm; 80 in each group. They were treated for 14 days.