What is baclofen used for?

Indications and Usage, quoted from the label by Method Pharmaceuticals LLC (ANDA212378). Cross-references to other label sections are left out.

Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.

Source: DailyMed label, set id 1a9db542-d2b0-141a-e063-6394a90acc11, version 2, effective July 23, 2025. NDC 58657-730, one of 201 listings for this product.

Indications and Usage, quoted from the label by Advagen Pharma Limited (ANDA217324). Cross-references to other label sections are left out.

Baclofen injection is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of baclofen injection via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses.

Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. Baclofen injection is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only with the Medtronic SynchroMed® II Programmable Pump or other pumps labeled for intrathecal administration of baclofen injection [see Clinical Studies].

Prior to implantation of a device for chronic intrathecal infusion of baclofen injection, patients must show a response to baclofen injection in a screening trial [see Dosage and Administration].

Source: DailyMed label, set id d63af5f0-c275-480b-89b5-6cf1ad55ab63, version 6, effective December 9, 2025. NDC 72888-145, one of 8 listings for this product.

Indications and Usage, quoted from the label by Sagent Pharmaceuticals (ANDA210048). Cross-references to other label sections are left out.

Baclofen injection (intrathecal) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of baclofen injection (intrathecal) via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy.

Spasticity of Spinal Cord Origin: Evidence supporting the efficacy of baclofen injection (intrathecal) was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of baclofen injection (intrathecal) to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis. Baclofen injection (intrathecal) was superior to placebo on both principal outcome measures employed: change from baseline in the Ashworth rating of spasticity and the frequency of spasms.

Spasticity of Cerebral Origin: The efficacy of baclofen injection (intrathecal) was investigated in three controlled clinical trials; two enrolled patients with cerebral palsy and one enrolled patients with spasticity due to previous brain injury. The first study, a randomized controlled cross-over trial of 51 patients with cerebral palsy, provided strong, statistically significant results; baclofen injection (intrathecal) was superior to placebo in reducing spasticity as measured by the Ashworth Scale. A second cross-over 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. The last study, however, did not provide data that could be reliably analyzed.

Baclofen injection (intrathecal) therapy may be considered an alternative to destructive neurosurgical procedures. Prior to implantation of a device for chronic intrathecal infusion of baclofen injection (intrathecal), patients must show a response to baclofen injection (intrathecal) in a screening trial (see Dosage and Administration).

Source: DailyMed label, set id 077aaf3b-1ca3-4599-a51a-6bbe39810ca8, version 1, effective June 24, 2021. NDC 25021-678, one of 4 listings for this product.