Omzya (tolperisone immediate release) / Sanochemia Pharma, Neurana - LARVOL DELTA

"XMReality and Viveo sign a partnership agreement and the first order is placed https://t.co/n4Ps36AICH" (@CisionNews)

Licensing / partnership

RESUME-1: Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm (clinicaltrials.gov) - P3 | N=1004 | Completed | Sponsor: Neurana Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed

Trial completion • Back Pain • Musculoskeletal Pain • Pain

Neurana Pharmaceuticals Seeks Strategic Alternatives Following Phase 3 Study (PRNewswire) - P3 | N=1,004 | RESUME-1 (NCT04671082) | Sponsor: Neurana Pharmaceuticals, Inc; | "Neurana Pharmaceuticals...announced that the 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....On Day 14, the efficacy of tolperisone did not demonstrate significance as compared to placebo. Tolperisone was safe and well tolerated with no serious adverse events. Somnolence, a key attribute of tolperisone, was similar to placebo."

P3 data • Back Pain • CNS Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

RESUME-1: Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm (clinicaltrials.gov) - P3 | N=1004 | Active, not recruiting | Sponsor: Neurana Pharmaceuticals, Inc. | Trial completion date: Jan 2022 ➔ Apr 2022

Trial completion date • Back Pain • Musculoskeletal Pain • Pain

RESUME-1: Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm (clinicaltrials.gov) - P3; N=1004; Active, not recruiting; Sponsor: Neurana Pharmaceuticals, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Back Pain • Musculoskeletal Pain • Pain

Neurana Pharmaceuticals Completes Patient Enrollment in Phase 3 RESUME-1 Study (PRNewswire) - "Neurana Pharmaceuticals...today announced it has completed enrollment of its 1,000 patient Phase 3 RESUME-1 Study of tolperisone for the relief of muscle spasm associated with acute, painful musculoskeletal conditions. Neurana anticipates reporting topline data in the first quarter of 2022."

Enrollment closed • Back Pain • Musculoskeletal Pain • Pain

Neurana Pharmaceuticals Announces Publication in Pain Management (PRNewswire) - "Neurana Pharmaceuticals...announced the publication of a manuscript, 'RESUME-1: A Phase III Study of Tolperisone in Treatment of Painful, Acute Muscle Spasms of the Back" in the journal of "Pain Management'....The study is designed to evaluate the efficacy and safety of tolperisone administered in subjects with pain due to acute back muscle spasms. Key secondary objectives include assessing the tolerability, onset of action, and need for rescue medication when treated with tolperisone."

P3 data • Back Pain • Pain

Neurana Pharmaceuticals Announces First Patient Enrolled in Phase 3, RESUME-1 Study (PRNewswire) - "Neurana Pharmaceuticals...today announced that the first patient has been enrolled in the Phase 3, RESUME-1, clinical study of tolperisone...for the treatment of symptoms associated with acute and painful muscles spasms of the back....The study will enroll patients across 70 clinical sites in the United States....Neurana anticipates reporting top-line data from the Phase 3 RESUME-1 Study in the fourth quarter of 2021."

Enrollment status • P3 data: top line • Back Pain • CNS Disorders • Musculoskeletal Pain • Pain

Neurana Pharmaceuticals Announces Top-Line Results from Tolperisone Phase 1 CNS Effects Study (PRNewswire) - P1, N=39; NCT04407377; Sponsor: Neurana Pharmaceuticals, Inc.; "Neurana Pharmaceuticals...today announced positive top-line results from the Phase 1 central nervous effects (CNS) clinical study of tolperisone. The study, utilizing a validated driving test, confirmed that tolperisone does not impair driving performance. In addition, tolperisone does not appear to cause sleepiness, a side effect often associated with currently available skeletal muscle relaxants....The study showed that volunteers taking tolperisone demonstrated no driving impairment with both the 200mg and 400mg doses used in the study....Treatment emergent adverse events (TEAEs) for placebo, tolperisone 200mg, tolperisone 400mg, and cyclobenzaprine were: 19.4%, 5.6%, 15.8%, and 33.3%, respectively."

P1 data • Back Pain • Musculoskeletal Pain • Pain

Neurana Pharmaceuticals Announces Publication in the Journal of Pain Research (PRNewswire) - P2, N=415; STAR (NCT03802565); Sponsor: Neurana Pharmaceuticals, Inc.; "Neurana Pharmaceuticals...today announced the publication of results from the dose-ranging Phase 2 STAR Study of tolperisone in patients with acute and painful muscle spasms of the lower back, in the Journal of Pain Research....Tolperisone was well tolerated with no serious adverse events reported. Overall, adverse events were reported in 18.1% of subjects receiving tolperisone versus 14.1% of subjects receiving placebo....'This data strengthens our confidence in our planned Phase 3 RESUME-1 study, for which we will begin enrollment imminently and anticipate topline data in the second half of 2021.'"

New P3 trial • P2 data • P3 data: top line • Back Pain • Musculoskeletal Pain • Pain

Neurana Pharmaceuticals to Present Tolperisone Data at PAINWeek National Conference (PRNewswire) - "Neurana Pharmaceuticals, a biotechnology pharmaceutical company focused on the treatment of neuromuscular conditions, today announced the acceptance of two scientific abstracts at the PAINWeek® 2020 National Conference which will take place virtually September 11-13, 2020."

Enrollment status • New P3 trial • P2 data • Back Pain • Musculoskeletal Pain • Pain

Neurana Pharmaceuticals announces first patient enrolled in CNS effects clinical study (PRNewswire) - "Neurana Pharmaceuticals, Inc....today announced that the first patient has been enrolled in the Phase 1 central nervous effects (CNS) clinical study of tolperisone, a novel skeletal muscle relaxant in development for the treatment of acute and painful muscle spasms without drowsiness or impact on cognititve function....The Phase 1 CNS effects study will utilize the expected commercial dose of tolperisone that will be taken into Phase 3 studies....Neurana anticipates reporting topline data for the Phase 1 study in the fourth quarter of 2020."

Enrollment status • P1 data • Muscle Spasticity • Musculoskeletal Pain • Pain

Neurana Pharmaceuticals announces publication of a driving study demonstrating the effects of tolperisone (PRNewswire) - "Neurana Pharmaceuticals, Inc....today announced the publication of a driving study which demonstrates the tolerability and safety of tolperisone in the peer-reviewed Journal of Clinical Pharmacy and Therapeutics. The publication, 'An assessment of the centrally acting muscle relaxant tolperisone on driving ability and cognitive effects compared to placebo and cyclobenzaprine,' reports results from the Phase 1, threeway, randomized, blinded, three-period crossover study....'The results from the study provide evidence that tolperisone does not impact driving ability nor cognitive function.'"

P1 data • Back Pain • CNS Disorders • Musculoskeletal Pain • Pain

Neurana Pharmaceuticals announces positive topline results from phase 2 STAR study of tolperisone in acute muscle spasms of the back (PRNewswire) - P2, N=415; STAR (NCT03802565); Sponsor: Neurana Pharmaceuticals, Inc.; "Neurana Pharmaceuticals...today announced positive topline results from the 'STAR Study', a Phase 2 dose-ranging study of tolperisone in acute muscle spasms of the back....Overall, the STAR Study demonstrated the efficacy of tolperisone with the 600 mg dose being highly significant (p=0.004) with sleepiness similar to placebo....Neurana plans to conduct an end-of-Phase 2 meeting with the FDA in the first quarter of 2020 and initiate Phase 3 clinical studies of tolperisone later in 2020."

FDA event • New P3 trial • P2 data

Neurana Pharmaceuticals announces completion of enrollment in the phase 2 study of tolperisone in acute muscle spasms of the back (PRNewswire) - "Neurana Pharmaceuticals...today announced that it has completed enrollment in the 'STAR Study,' a Phase 2 dose ranging study of tolperisone in acute muscle spasms of the back in over 400 patients....'We are very pleased to complete patient enrollment in the STAR Study, and we plan to announce topline efficacy data later this year.'"

Enrollment closed • P2 data