From the Parkinson’s Disease Foundation
Days after the initial announcement, the Parkinson’s Disease Foundation—one of the leading organizations in the Parkinson’s disease community—included this information in a news release:
In 2006, the FDA approved Azilect as a stand- alone treatment for people with early Parkinson’s and as a treatment in conjunction with levodopa for people with more advanced Parkinson's. If the FDA should approve its new request, this would be the first treatment to be marketed in the US for a disease-slowing property.
The value of Azilect as a treatment to ease Parkinson’s symptoms has been well demonstrated over several years of successful use by thousands of patients. Its value as a neuroprotective has been suggested by an earlier, smaller study, but has not been proven. The new study – and the FDA’s response to this – may help to clarify Azilect’s potential in this area but we will not know for sure until the data have been released.
Several weeks later the Parkinson’s Disease Foundation, released the following in regards to Teva’s announcement:
On June 16, Teva Pharmaceuticals issued an announcement about the results of its Phase III clinical trial, ADAGIO, which tested the neuroprotective abilities of Azilect® (rasagiline), a medication already on the market for the treatment of the signs and symptoms of Parkinson's disease. Teva announced that it had applied to the U.S. Food and Drug Administration (FDA) for approval to market Azilect for its potential to slow the course of the disease.
It was announced that the data from ADAGIO, which has not yet been released, will be presented at the 12th Congress of European Federation of Neurological Societies (EFNS) on August 26, 2008 in Madrid, Spain.
Once the results of Teva’s study have been released, medical experts will be able to openly analyze the data and reaffirm or refute their findings.
More About Azilect
Until then, here is some additional information about Teva, how it works, and special considerations Parkinson’s patients should make when considering this treatment.
Azilect, which was developed under the name rasagiline, helps prevent breakdown of dopamine. Dopamine is a chemical produced in the brain that helps control muscle movement by facilitating signals between cells.
Currently, Azilect is approved as a stand-alone therapy for newly diagnosed Parkinson’s disease patients. It can be used as soon as a diagnosis is reached. Levodopa is one of the most common Parkinson’s treatments. Azilect is not meant to replace levodopa or other treatments such as dopamine agonists. However, Azilect can be used in conjunction with those medications.
Azilect is also approved for and effective as a supplemental medication to levodopa in moderate-to-advanced stages of the disease. When combined with levodopa, Azilect reduces “off” times, or in other words, Azilect helps control and reduce symptoms as levodopa begins to wear off.
Possible Complications with Azilect
There are some precautions Parkinson’s patients need to be aware of when discussing Azilect with their doctors. First, patients with liver disease or a tumor of the adrenal gland should not take Azilect. There are also several potentially dangerous drug interactions. If patients are taking any of the following medications, they should not add Azilect to their treatment plan:
- MOA inhibitors
- Tramadol
- Methadone
- Propoxyphene
- Dextromethorphan
- St. John’s Wort
- Antidepressants
- Mirtazapine
- Cyclobenzaprine
- Non-prescription cold remedies with decongestants
- Local anesthetics
- Anything that raises blood pressure
- CYP1A2 inhibitors (such as ciprofloxacin)
Even certain foods can have a negative or potentially dangerous reaction with Azilect. Patients taking Azilect should avoid foods, beverages, and supplements rich in tyramine (a natural substance that forms as protein breaks down in aged foods) like:
- Aged cheeses
- Air-dried meats
- Pickled herring
- Yeast extract
- Aged red wines
- Tap/draft beers
- Sauerkraut
- Soy sauce
Eating those foods can cause severe headaches, blurred visions, difficulty thinking, seizures, chest pain, nausea, vomiting, or stroke. Anyone experiencing those symptoms should seek immediate medical attention.
There are some general side effects associated with Azilect as well. Some of the minor side effects when Azilect is taken alone include joint pain and indigestion. When taken with levodopa, side effects such as uncontrolled movements (dyskinesias), weight loss, standing low blood pressure, vomiting, joint pain, nausea, constipation, dry mouth, rash, and sleepiness can occur. Patients should discuss any such side effects with their doctors.
Other more serious side effects such as hallucinations have occasionally been reported. Patients should seek immediate medical attention if any unusual and severe side effects occur.