No distinct clinical trial of OZOBAX has been performed. The efficacy of OZOBAX is based on a bioavailability study in healthy adults comparing baclofen oral tablets to OZOBAX.
- A pharmacokinetic study in healthy adult male subjects under fasting conditions at a 20 mg dose level demonstrated similar bioavailability for baclofen oral solution 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
- OZOBAX (baclofen) oral solution Prescribing Information. Revised 09/2019. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208193s000lbl.pdf. Accessed Feb. 13, 2020.>
- 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.
- 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