ITB Therapy℠ with Lioresal® Intrathecal (baclofen injection) has a well-established safety and efficacy profile for severe spasticity. It is approved to treat severe spasticity of both cerebral and spinal origins.1
Before implantation of the SynchroMed® II infusion system, patients must show a positive response to Lioresal® Intrathecal in a screening trial.
Efficacy for Severe Spasticity of Spinal Origin
A controlled clinical investigation (Penn et al. 1989) in patients with severe spasticity due to multiple sclerosis (MS) and spinal cord injury (SCI) demonstrated the efficacy and safety of ITB Therapy℠ with Lioresal® Intrathecal and served as the basis for US Food and Drug Administration (FDA) approval for severe spasticity of spinal origin spasticity in 1992. This study compared the effects of either a single intrathecal dose or a 3-day infusion of Lioresal® Intrathecal to placebo, demonstrating the superiority of Lioresal® Intrathecal in change from baseline in the Ashworth Scale for spasticity and the change from baseline in the frequency of spasms.1
This study was supported by additional studies, including studies in patients with spasticity from cerebral origin, pediatric patients, screening trials, and open-label, long-term (up to 7 years) extension trials (see Penn 1992; Coffey et al. 1993).
Efficacy for Severe Spasticity of Cerebral Origin
The efficacy of Lioresal® Intrathecal was investigated in 3 controlled clinical trials: 2 trials enrolled patients with cerebral palsy and 1 enrolled patients with spasticity due to previous brain injury or stroke. These trials were the basis of FDA approval for spasticity of cerebral origin in 1996, as they demonstrated significant reduction in spasticity. Note that there is no safety or efficacy data in children under 4 years of age or in patients less than 1 year after traumatic brain injury.1
The first study, a randomized controlled crossover trial of 51 patients with cerebral palsy, and demonstrated statistically significant superiority of Lioresal® Intrathecal compared to placebo in reducing spasticity as measured by the Ashworth Scale (see Gilmartin et al. 2000). This study was conducted after Albright et al. published data demonstrating efficacy of ITB Therapy℠ with Lioresal® Intrathecal in both pediatric and adult patients with cerebral palsy.
A second crossover study was conducted in 11 patients with spasticity arising from brain injury. Despite the small sample size, the study yielded a nearly significant test statistic (P=0.066) and provided directionally favorable results (see Meythaler et al. 1996). The last study, however, did not provide data that could be reliably analyzed.1
Supportive data and long-term efficacy of ITB Therapy℠ with Lioresal® Intrathecal were demonstrated in additional trials.
The most frequent drug adverse events vary by indication but include: hypotonia (34.7%), somnolence (20.9%), headache (10.7%), convulsion (10.0%), dizziness (8.0%), urinary retention (8.0%), nausea (7.3%), and paresthesia (6.7%). Dosing and programming errors may result in clinically significant overdose or withdrawal. Acute massive overdose may result in coma and may be life threatening. Drowsiness has been reported in patients on Lioresal® Intrathecal. Patients should be cautioned regarding the operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system depressant effects of Lioresal® Intrathecal may be additive to those of alcohol and other CNS depressants. Seizures have been reported during overdose and with withdrawal from Lioresal® Intrathecal as well as in patients maintained on therapeutic doses of Lioresal® Intrathecal. Fatalities have been reported with Lioresal® Intrathecal use. The most frequent and serious adverse events related to device and implant procedures are catheter dislodgement from the intrathecal space, catheter break/cut, and implant site infection including meningitis. Electromagnetic interference (EMI) and magnetic resonance imaging (MRI) may cause patient injury, system damage, operational changes to the pump, and changes in flow rate.
- Lioresal® Intrathecal (baclofen injection) for intrathecal injection [prescribing information]. Saol Therapeutics, Roswell, Georgia; January 2019.
- Penn RD, Savoy SM, Corcos D, et al. Intrathecal baclofen for severe spinal spasticity. N Engl J Med. 1989;320(23):1517-1521.
- Coffey RJ, Cahill D, Steers W, et al. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study. J Neurosurg. 1993;78(2):226-232.
- Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years of experience. J Neurosurg. 1992;77(2):236-240.
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