Why OZOBAX® DS

EFFECTIVE TREATMENT OF SPASTICITY
IN A FLEXIBLE AND CONVENIENT 10mg/5mL ORAL SOLUTION1

OZOBAX DS provides the clinical benefits of baclofen in an oral solution that simplifies titration, enables precise dosing, and provides an easy to swallow medicine for patients with dysphagia. Compared to the 5mg/5mL formulation of baclofen oral solution, OZOBAX DS provides the same total mg dose in half the total dose in volume. OZOBAX DS does not require refrigeration.

In MS, oral baclofen demonstrated significantly better efficacy than placebo at improving muscle tone.2

55%-72% of patients experienced an improvement with baclofen compared with the 0%-17.4% of patients who were given placebo.

In open-label studies of oral baclofen, spasticity was improved in 70%-87% of patients who had spasticity of spinal origin.3

Improvement in spasms was reported in 75%-96% of all patients.

Dosing Flexibility and Precision

OZOBAX DS provides a flexible solution that can be tailored to meet individual patient needs.  Initiate OZOBAX DS with a low dosage, preferably in divided doses, administered orally. The dosage can be increased gradually based on clinical response and tolerability1.

A Solution for Patients with Dysphagia

Data suggest greater than 40% prevalence of dysphagia in patients with MS.4 OZOBAX DS is an oral solution that may help your patients who have difficulty swallowing baclofen in tablet form. Compared to the 5mg/5mL formulation of baclofen oral solution, OZOBAX DS provides the same total mg dose in half the total dose in volume.

No Refrigeration Storage

OZOBAX DS does not require refrigeration. Store at 20°C to 25°C (68°F to 77°F).


References:

  1. OZOBAX DS [prescribing information]. Athens, GA: Metacel Pharmaceuticals, LLC; 2022.
  2. ERTZGAARD P, CAMPO C and CALABRESE A. EFFICACY AND SAFETY OF ORAL BACLOFEN IN THE MANAGEMENT OF SPASTICITY: A RATIONALE FOR INTRATHECAL BACLOFEN. J Rehabil Med 2017; 49: 193–203.
  3. Dario, A., Tomei, G. A Benefit-Risk Assessment of Baclofen in Severe Spinal Spasticity. Drug-Safety 27, 799–818 (2004) doi:10.2165/00002018-200427110-00004
  4. Aghaz A, Alidad A, Hemmati E, Jadidi H, Ghelichi L. Prevalence of dysphagia in multiple sclerosis and its related factors: systematic review and meta-analysis. Iran J Neurol. 2018;17(4):180–188.

 

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.