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Arbaclofen extended-release tablets for spasticity in multiple sclerosis: open-label extension study.

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Area of Science:

  • Neurology
  • Pharmacology
  • Clinical Trials

Background:

  • Baclofen, a GABA-B agonist, treats multiple sclerosis spasticity but has dosing and tolerability issues.
  • Arbaclofen, the R-enantiomer of baclofen, offers higher receptor specificity and potency.
  • Arbaclofen extended-release (ER) demonstrated favorable safety and efficacy in Phase 3 trials.

Purpose of the Study:

  • To evaluate the long-term safety and efficacy of arbaclofen ER in adult patients with multiple sclerosis-related spasticity.
  • To assess adverse events, tolerability, and sustained spasticity reduction over a 52-week period.

Main Methods:

  • A 52-week, open-label, multicenter extension study of a Phase 3 trial.
  • Adults with moderate to severe spasticity received arbaclofen ER titrated up to 80 mg/day.
  • Safety and efficacy were assessed using clinical scales, including the Numeric-transformed Modified Ashworth Scale (NTMAS) and patient-reported outcomes.

Main Results:

  • 218 of 323 patients (67.5%) completed the 1-year study.
  • Most patients (74.0%) reached an 80 mg/day maintenance dose.
  • 86.1% experienced treatment-emergent adverse events, mostly mild-moderate, with common events including urinary tract disorder, muscle weakness, and asthenia.
  • 14.9% discontinued due to adverse events.
  • Sustained improvement in multiple sclerosis-related spasticity was observed.

Conclusions:

  • Arbaclofen ER (up to 80 mg/day) was well-tolerated and effective for long-term management of multiple sclerosis spasticity in adults.
  • The treatment provided sustained reduction in spasticity symptoms over 52 weeks.
  • Arbaclofen ER represents a viable therapeutic option for patients needing chronic spasticity management.