Pain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine - Takeaways - MDSpire

Pain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine

  • By

  • Seth Lederman

  • Lesley M Arnold

  • Ben Vaughn

  • Jean M Engels

  • Mary Kelley

  • Gregory M Sullivan

  • July 8, 2025

  • 0 min

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  • 1

    Sublingual cyclobenzaprine (TNX-102 SL) 5.6 mg significantly reduced pain and improved sleep quality in fibromyalgia patients compared to placebo.

  • 2

    The phase 3 trial demonstrated that 81% of TNX-102 SL patients completed the study, indicating good tolerability.

  • 3

    Treatment with TNX-102 SL resulted in significant improvements across all secondary endpoints, including fatigue and overall function.

  • 4

    Common treatment-emergent adverse events were mild and transient, primarily related to oral administration, such as oral hypoesthesia.

  • 5

    The study validates previous findings on the efficacy of TNX-102 SL in managing fibromyalgia symptoms, addressing a significant treatment gap.

Original Source(s)

Pain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine

  • by Seth Lederman, Lesley M Arnold, Ben Vaughn, Jean M Engels, Mary Kelley, Gregory M Sullivan

  • July 8, 2025

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