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Kemstro (Baclofen) - Summary



KEMSTRO™ (baclofen orally disintegrating tablets)

KEMSTRO™ (baclofen orally disintegrating tablets) is a muscle relaxant and antispastic. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid.

KEMSTRO™ is 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 treatment with KEMSTRO™ will aid in restoring residual function.

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

KEMSTRO™ is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

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

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Media Articles Related to Kemstro (Baclofen)

Baclofen Pump (Therapy for Multiple Sclerosis)
Source: MedicineNet Muscle Cramps Specialty [2015.05.27]
Title: Baclofen Pump (Therapy for Multiple Sclerosis)
Category: Procedures and Tests
Created: 1/31/2005 12:00:00 AM
Last Editorial Review: 5/27/2015 12:00:00 AM

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Published Studies Related to Kemstro (Baclofen)

Baclofen for the Treatment of Alcohol Dependence and Possible Role of Comorbid Anxiety. [2014]
baclofen in the treatment of alcohol dependence... CONCLUSIONS: In spite of the small sample for a 3-arm clinical trial, this study

Randomised clinical trial: arbaclofen placarbil in gastro-oesophageal reflux disease--insights into study design for transient lower sphincter relaxation inhibitors. [2013]
characteristics of patients who were responders... CONCLUSIONS: Arbaclofen placarbil was not superior to placebo in the primary

Baclofen reduces binge eating in a double-blind, placebo-controlled, crossover study. [2012]
Baclofen has shown promise in treating substance use disorders and also reduced binge frequency in an open-label trial...

Defining the Role of Baclofen for the Treatment of Alcohol Dependence: A Systematic Review of the Evidence. [2011.12.06]
The pharmacological properties of baclofen, a GABA(B) receptor agonist, have led to investigation of its use for the off-label treatment of alcohol dependence. Literature examining the role of baclofen in alcohol dependence suggests that it may be a useful medication in the treatment armamentarium with an additional benefit of promoting abstinence and reducing alcohol-associated cravings and anxiety...

treating alcohol withdrawal with oral baclofen: a randomized, double-blind, placebo-controlled trial. [2011.10]
BACKGROUND: Abrupt cessation of alcohol intake causes habituated drinkers to experience symptoms of alcohol withdrawal syndrome (AWS). OBJECTIVE: To determine the effect of the gamma-aminobutyric acid (GABA)-B agonist baclofen on the course of acute symptomatic AWS... CONCLUSIONS: We found that the use of baclofen was associated with a significant reduction in the use of high doses of benzodiazepine (lorazepam) in the management of symptomatic AWS. The use of low-dose baclofen in the management of AWS deserves further study, as reduced dependence on high-dose benzodiazepines in AWS management could improve patient safety. Copyright (c) 2011 Society of Hospital Medicine.

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Clinical Trials Related to Kemstro (Baclofen)

Baclofen for Smoking Cessation in a Non-Psychiatric Population [Terminated]
The primary hypothesis for this study is that, in nicotine-dependent tobacco smokers, baclofen will be superior to placebo for smoking abstinence measures. The secondary hypothesis is that subjects assigned to the baclofen groups will exhibit higher rates of medication compliance (i. e. take the medication as directed for the trial period) than those in the placebo group. The tertiary hypothesis is that baclofen will lead to significant reductions in tobacco withdrawal and craving ratings as compared to placebo.

Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis [Recruiting]
Patients with cirrhosis often experience muscle cramps with varying severity. The mechanism of their occurrence is not yet understood. Muscle cramps in patients with cirrhosis are associated with significantly diminished quality of life. The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps in patients with liver cirrhosis.

Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump [Active, not recruiting]

Oral and IV Baclofen in Adult Volunteers [Completed]
The primary objective of this study is to characterize baclofen pharmacokinetics following oral and intravenous administration in patients who are on chronic oral baclofen therapy. The secondary objective is to determine the safety profile of an IV baclofen formulation. This study is a randomized crossover study with two treatment arms. All subjects will receive a dose of oral baclofen and a dose of IV baclofen on separate study days. Whether the oral or intravenous form is given on the first study day will be randomized in a 1: 1 manner. The pharmacokinetic and tolerability information gained from this study will support the development of further studies to assess the use of IV baclofen to prevent or treat baclofen withdrawal syndrome.

Action of Baclofen Capsules in Spasticity Due to Multiple Sclerosis [Recruiting]
This is a double-blind, randomized, placebo-controlled trial to evaluate duration of action of Baclofen ER capsules (GRS) compared with placebo in subjects with spasticity due to Multiple sclerosis. The trial will include male and female subjects greater than or equal to 18 years of age with spasticity with multiple sclerosis.

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Page last updated: 2015-05-27

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