OZOBAX® DS Efficacy Data

No distinct clinical trial of OZOBAX DS has been performed. The efficacy of OZOBAX DS is based on a bioavailability study in healthy adults comparing baclofen oral tablets to OZOBAX DS.

  • A pharmacokinetic study in healthy adult male subjects under fasting conditions at a 20 mg dose level demonstrated similar bioavailability for baclofen oral solution (5 mg/5 mL) and oral tablets.1
  • While the oral form of baclofen is rapidly absorbed in the gut lumen, it has difficulty crossing the bloodbrain barrier.2
  • For the oral solution, the peak plasma concentrations are achieved in about 0.75 hours and the bioavailable half-life is about 5.7 hours.1
  • With both oral forms, approximately 70% of baclofen never metabolizes and is eliminated unchanged in the urine, with the remainder excreted in the feces.3

References:

  1. OZOBAX DS [prescribing information]. Athens, GA: Metacel Pharmaceuticals, LLC; 2022.
  2. Chang E., A Review of Spasticity Treatments: Pharmacological and Interventional Approaches. Crib Rev Phys Rehabil Med. 2013; 25(1-2): 11–22. doi:10.1615/CritRevPhysRehabilMed.2013007945.
  3. Ghanavatian S, Derian A. Baclofen. [Updated 2019 Oct 1]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2019 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK526037. Accessed Jan. 30, 2020

 

Indications and Usage

OZOBAX DS is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

OZOBAX DS  may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Limitations of Use: OZOBAX DS  is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

Important Safety Information

OZOBAX DS is contraindicated in patients with hypersensitivity to baclofen.

Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when OZOBAX DS is discontinued.

Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue OZOBAX DS before delivery.

OZOBAX DS can cause drowsiness and sedation. Patients should avoid the operation of machinery until they know how the drug affects them. Advise patients that the central nervous system effects of OZOBAX DS may be additive to those of alcohol and other CNS depressants.

OZOBAX DS should be used with caution in patients who have had a stroke.

OZOBAX DS can cause exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy. Use with caution in patients with these conditions.

The most common adverse reactions (>1%) in patients treated with baclofen for spasticity are drowsiness, dizziness, weakness, nausea, confusion, hypotension, headache, insomnia, constipation, urinary frequency and fatigue.

You are encouraged to report adverse reactions to Metacel Pharmaceuticals, LLC at 1-833-469-6229 or to the FDA:  www.fda.gov/medwatch or 1-800-FDA-1088.

Please see the accompanying Full Prescribing Information.