Parkinson's Disease
Drug Azilect Approved By FDA - Treatment For Early Stage and Late State
with Levodopa - Side Effects
May 17th 2006
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The Food and Drug
Administration (FDA) approved a new drug by Israeli drug maker Teva
Pharmaceutical Industries in Tel Aviv for the treatment of Parkinson’s
disease. The molecular identity is called Azilect (rasagiline) and is a
monoamine oxidase type--B (MAO-B) inhibitor that blocks the breakdown of
dopamine. Dopamine is a chemical that sends information to the parts of
the brain that control movement and coordination.
The drug has been
approved for both early and late stages of the disease. Azilect was
approved for use as an initial single drug therapy in early Parkinson's
disease, and as an addition to levodopa for advanced stages. Levodopa
has been a standard treatment for Parkinson’s disease.
Dr. Steven Galson
said "This is a welcome development for the more than 50,000 Americans
who are each year diagnosed with Parkinson's disease. Parkinson's is a
relentless disease with limited treatment options, and each new therapy
is an important addition to the physicians' treatment options." Galson
is Director of the Center for Drug Evaluation and Research.
According to the
FDA, the safety and efficacy was demonstrated in three 18- to 26-week
controlled clinical trials. The first study compared the effects of
Azilect with the effects of placebo in 404 patients with early
Parkinson's disease. The patients who took Azilect showed significantly
less worsening on a rating scale that measures the ability to perform
mental and motor tasks as well as daily living activities.
Levodopa was added
to Azilect in the other two studies. The effects of Azilect with
placebo when taken together with levodopa by over 1100 patients with
more advanced Parkinson's. They found that patients who took the
combination therapy had significantly less time per day with relatively
poor function and mobility as compared with patients on levodopa and
placebo.
The FDA report
says that patients who also consume tyramine-rich foods, beverages (such
as cheese and red wine) or dietary supplements or amines contained in
many cough/cold medications may have a “hypertensive crisis”. They say
patients will need to avoid these sources of tyramine and amines when
taking Azilect.
The FDA warns that
most Parkinson’s drugs, including Azilect have the potential to cause
involuntary movements (dyskinesias), hallucinations and lowered blood
pressure. These side effects are described in the product labeling.
Also, during
development, melanoma was diagnosed in a small number of patients
treated with Azilect. Although the FDA has concluded that the available
data do not establish that Azilect is associated with an increased risk
for melanoma, it appears that compared to the general population,
patients with Parkinson's disease have an increased risk for this form
of skin cancer. In order to address the question of whether or not
Azilect itself increases such risk, the drug's manufacturer will perform
a Phase 4 (postmarket) study. The product labeling will recommend that
patients undergo periodic dermatologic examinations.
Dan Wilson
Best Syndication
Books on the Mind
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