an oral suspension for treating spasticity

Baclofen is a proven therapy for the treatment of spasticity

  • Healthcare professionals have been prescribing baclofen to treat spasticity for more than 40 years1
  • Baclofen is a commonly prescribed medication to treat spasticity in MS2
  • A phase 1 bioequivalence study was performed between FLEQSUVYTM and baclofen oral tablets that demonstrated bioequivalence. The bioequivalence study established a scientific bridge for safety and efficacy between FLEQSUVYTM and baclofen oral tablets1
  • While clinical trials with FLEQSUVYTM have not been performed, previous studies with baclofen have demonstrated efficacy and safety for the indicated use of FLEQSUVYTM 3

FLEQSUVYTM is a liquid formulation of baclofen1

  • Pharmacokinetic Summary:
  • Absorption: Peak plasma concentrations were achieved in about 1 hour from administration of FLEQSUVYTM in the fasted state. The apparent elimination half-life is about 5.6 hours
  • Effect of Food: Administration of FLEQSUVYTM with a high-fat meal resulted in a 9% decrease in the AUC and a 33% decrease in Cmax compared to the fasted state
  • Elimination: Baclofen is excreted primarily by the kidneys in unchanged form, and there is relatively large intersubject variation in absorption and/or elimination

AUC=area under the curve; Cmax=maximum plasma concentration.

A well-documented safety profile1

  • Clinical trials are conducted under widely varying conditions; therefore adverse reaction rates may vary in different trials
  • In the bioavailability study for FLEQSUVYTM, no deaths occurred and all treatment-associated adverse events were assessed as mild in intensity. One subject discontinued due to increased blood creatinine phosphokinase and increased blood creatinine
  • In clinical trials for baclofen, the most common adverse reactions* were transient drowsiness (10% to 63%) and dizziness and weakness (5% to 15%)
  • Other adverse reactions (≥1%) were nausea, confusion, hypotension, headache, insomnia, constipation, urinary frequency, and fatigue
  • The following laboratory tests have been found to be abnormal in patients receiving baclofen: increased SGOT (serum glutamic oxaloacetic transaminase), elevated alkaline phosphatase, and elevation of blood sugar

*For complete list of adverse reactions for FLEQSUVYTM, see full Prescribing Information.