How Azilect works
Parkinson’s disease is a neurodegenerative disorder, where nerve cells in the brain that produce dopamine (a chemical messenger that sends signals between brain cells) slowly die. Dopamine is essential to sending messages to coordinate movement, and decreasing levels result in a progressive loss of control over movement and various other symptoms.
Azilect is a monoamine oxidase-B (MAO-B) inhibitor, that acts to increase the levels of dopamine in the brain. MAO-B is an enzyme (a catalyst that triggers a chemical reaction) that normally breaks down dopamine, to prevent levels from increasing too high. By stopping this enzyme from working Azilect can allow the body to maintain the small amount of dopamine Parkinson’s patients produce for longer. This can restore some dopamine communication and reduce motor symptoms.
It is frequently prescribed alongside a levodopa treatment. Levodopa is a chemical that is converted into dopamine in the brain. Azilect prevents this dopamine from being broken down, extending the time the levodopa therapy is active. This decrease the “off” time patients experience between levodopa doses, where the symptoms start to return before the next dose of levodopa medication is taken.
Azilect in clinical trials
It has received full approval by the U.S. Food and Drug Administration (FDA) for the treatment of Parkinson’s disease on May 17, 2006. The FDA revised the prescribing information for Azilect on December 14, 2009, to remove the tyramine dietary restriction, based on clinical studies carried out by Teva Pharmaceuticals. The initial approval of Azilect was based on four key clinical trials.
The first study (NCT00203060) assessed Azilect as the sole treatment for Parkinson’s disease and showed a significant improvement in patients treated with 1 mg or 2 mg of Azilect compared to a placebo using the Unified Parkinson’s Disease Rating Scale (UPDRS). The UPDRS assesses how the motor and non-motor symptoms of Parkinson’s disease affect daily activities, the overall motor ability of the patient, and whether there are any complications associated with the use of medication. There was no difference between 1 mg or 2 mg. The trial demonstrated that taking Azilect resulted in an improvement in UPDRS scores and a reduction in the duration of “off” time patients experience between levodopa doses by over an hour.
The other three trials all assessed Azilect as an adjunct therapy to levodopa treatment. In these studies, the participants were randomly assigned to either receive Azilect or a placebo whilst also taking levodopa.
Azilect has continued to be tested in clinical trials after approval. Teva Pharmaceuticals carried out the large-scale ADAGIO study (NCT00256204) in 1174 participants. The results of this study were published in the scientific journals, the New England Journal of Medicine in 2009, and in The Lancet Neurology in 2011. They suggested that 1 mg prescribed in early-stage Parkinson’s disease patients may delay the need to start treatments such as levodopa, and therefore could modify how the disease advances. However, a further understanding of the disease progression is needed to make a conclusive statement.
The most common side effect experienced by patients taking Azilect is dyskinesia (involuntary movements).
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