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News in Brief
Azilect® Approved for Parkinson's
On May 17, the US Food and Drug Administration (FDA) approved a new drug, Azilect® (rasagiline), as a once-daily treatment for Parkinson's disease. The approval stated that Azilect® was determined to be safe and effective as a monotherapy for early Parkinson's, and as a treatment in conjunction with levodopa for people with more advanced Parkinson's. Marketed by Teva Pharmaceutical Industries, Azilect® is a monoamine oxidase type-B (MAO-B) inhibitor, which blocks the breakdown of dopamine in the brain.
Teva presented the FDA with data from three multi-center studies of more than 1,600 people with Parkinson's disease. One study compared the effects of Azilect® treatment in people with early-stage Parkinson's disease to another group on placebo, and found that the Azilect® group experienced a lower rate of worsening of symptoms. The other two studies compared placebo groups with people with more advanced disease taking Azilect® in addition to levodopa. The Azilect® group demonstrated significantly less "off" time than people in the placebo group.
As with all MAO-B inhibitors, Azilect® can cause serious problems with hypertension when taken with foods, beverages and dietary supplements that contain tyramine. This substance is found in draft beer, red wine, fava beans, aged cheeses, soy sauce and other products. Other side-effects observed during the studies include dyskinesias, hallucinations and lowered blood pressure. Teva announced that Azilect® became available in US pharmacies in late July.
Zelapar® Okayed as Adjunct Therapy
On June 15, Valeant Pharmaceuticals announced the FDA approval of Zelapar®, its oral disintegrating formula of selegiline, to be marketed for Parkinson's disease. Selegiline is a MAO-B inhibitor, which blocks the breakdown of levodopa in the brain. The once-a-day tablets were approved as a supplementary treatment for people with Parkinson's who are already on levodopa/carbidopa therapy and for whom this combination is losing effectiveness.
Zelapar® dissolves in the mouth within seconds, releasing more of the active drug at a smaller dose (compared with traditional Parkinson's therapies). The dissolvable tablet may be helpful for people who experience difficulty with swallowing.
In data submitted to the FDA by the company, Zelapar® was shown to decrease "off" time by an average of 2.2 hours per day, compared with a decrease of 0.6 hours per day in people receiving a placebo. Side-effects reported include nausea, dizziness, pain and insomnia.
Dementia Drug Approved for Parkinson's
Novartis announced on June 27 that the US Food and Drug Administration (FDA) has approved the use of Exelon® for the treatment of mild to moderate dementia associated with Parkinson's disease. Exelon® (rivastigmine tartrate) was already approved in the US for treating Alzheimer's dementia and is the first and only treatment available for Parkinson's dementia.
The FDA approval was based on findings from Novartis' clinical trial called EXPRESS (the EXelon in PaRkinson's disEaSe dementia Study), which were published in the December 9, 2004 issue of The New England Journal of Medicine. EXPRESS evaluated the safety and efficacy of Exelon® in treating people with Parkinson's dementia by enrolling 541 people from 12 study centers in Europe and Canada and randomly assigning participants to an Exelon® treatment group or a placebo group. This was the first large-scale, placebo-controlled study to show significant statistical benefit in people with Parkinson's who have problems with dementia.
Over 24 weeks, participants in the Exelon® treatment group received a gradually increasing dose (up to 12 mg) of the medication. The results showed that this group experienced a significant improvement in overall functioning, cognition and other aspects of behavior compared to those taking a placebo. Assessments were made with Alzheimer's disease rating scales to determine the improvement of dementia symptoms.
Side-effects present during the study included nausea and vomiting, and some patients in the Exelon® group reported increased tremor.