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Kemstro (Baclofen) - Summary

 
 



KEMSTRO 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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NEWS HIGHLIGHTS

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 [Recruiting]
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.

Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity [Recruiting]
Oral baclofen is used commonly to treat spasticity in children with cerebral palsy. Although for adults there is dosing,safety and efficacy information in the package insert, this is not the case for children. The purpose of this study is to determine how fast the drug is cleared from the body, the correct dose, and long-term safety and efficacy for children with spasticity.

Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump [Not yet recruiting]

Oral and IV Baclofen in Adult Volunteers [Not yet recruiting]
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.

Transcranial Magnetic Stimulation (TMS) Measures of Plasticity and Excitatory/Inhibitory Ratio as Biomarkers: R-baclofen Effects in Normal Volunteers [Recruiting]
Our overall objective is to apply Transcranial Magnetic Stimulation (TMS) to develop measures of human synaptic plasticity and of brain excitatory: inhibitory ratio (E: I ratio), which we propose as novel biomarkers and outcome measures that will expedite clinical trials of treatments for Autism Spectrum Disorder (ASD). One potential therapeutic agent, R-baclofen will be investigated under this protocol.

TMS is a safe, inexpensive and noninvasive means to focally stimulate the human brain. Presently, TMS is in extensive use as a means to measure regional brain excitability, which is dependent on local synaptic strength. TMS can be used to temporarily alter synaptic strength as well as to acutely measure levels of cortical excitability and short and long interval inhibition. Since altered synaptic plasticity and an imbalanced inhibitory: excitatory ratio are cited as fundamental abnormalities in ASD, we hypothesize that both severity of ASD-related learning deficits and their improvement after therapy will correlate with TMS measures of synaptic plasticity and E: I ratio. We propose to embed TMS measures of synaptic plasticity and E: I ratio in a 'Proof of Principal' trial of R-baclofen and to examine:

Aim 1: Whether R-baclofen (a potential therapeutic agent for ASD) predictably alters TMS measures of synaptic plasticity and E: I ratio as a function of plasma concentration in adult volunteers. We will test the following hypotheses:

1. R-baclofen produces a significant change in TMS measures of LTD and E: I ratio; and

2. R-baclofen plasma levels and TMS measures of LTD and E: I ratio show a predictable exposure-response relationship.

Exploratory Aim 1: Whether the presence of genetic polymorphisms of the BDNF and GABA-B receptor genes has a moderating effect on TMS measures and on R-baclofen effects. We will test the following hypotheses:

1. Presence of the BDNF val66met allele will be associated with decreased long-term depression (LTD) of cortical excitability

2. Polymorphisms of GABA-B receptor genes will be associated with altered magnitude of response to R-baclofen as measured by TMS

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Page last updated: 2014-11-30

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