Teva Pharmaceuticals announced it may have found a drug treatment that can slow the progression of Parkinson's disease in the early stages, according to a company news release.
Azilect, the branded name of the drug rasagiline, could become the first Parkinson's disease treatment to receive a label for disease modification. In other words, instead of treating symptoms only of Parkinson's disease, Azilect treats the disease.
"This scientific breakthrough addresses one of the most critical unmet needs in the treatment of patients with Parkinson's disease," said Dr. Ben-Zion Weiner, Teva's chief research and development officer, in a news release.
The 18-month study was a Phase III clinical trial and was the first of its kind. It was one of the largest conducted in Parkinson's disease, involving 1,176 patients with early Parkinson's disease in 14 countries and 129 medical centers. Participants were randomly assigned to receive a 1 mg or 2 mg dose of Azilect or a placebo.
The group that received the 1 mg dose of Azilect had the most statistically significant results and achieved all endpoints, or goals, for the study. However, the results of the group taking 2 mg doses were also favorable. Researchers hope to conduct more statistical analysis of the data to better understand the implications of the information.
Teva intends to submit these results to the regulatory authorities in the United States and Europe. Azilect (rasagiline) 1 mg tablets are currently available for treatment of Parkinson's disease symptoms in 30 countries, including the United States, Canada, Israel, Mexico, and most of the EU countries.
Azilect (rasagiline) tablets are currently indicated for the treatment of the signs and symptoms of Parkinson's disease both as initial therapy alone and to be added to levodopa later in the disease. It blocks the breakdown of dopamine. It reduces "off" time and improves motor function in Parkinson's disease patients with levodopa-related motor fluctuations.
While rasagiline has been proven to be an effective treatment for Parkinson's symptoms, there are some side effects and precautions patients should be aware of when considering adding rasagiline to their therapy program. Patients should alert their doctors if they experience any of the following side effects:
- mild headache, or joint or neck pain
- heartburn ,stomach pain, constipation, or diarrhea
- loss of appetite or weight loss
- flu-like symptoms, fever, sweating, runny nose, or red, swollen, and/or itchy eyes
- dry mouth
- unsteadiness, wobbliness, or lack of coordination
- lack of energy, sleepiness, or depression
- pain, burning, numbness, or tingling in the hands or feet
- rash
- black and blue marks
Rasagiline can increase blood pressure significantly and cause some of these other, more serious side effects:
- severe headache, blurred vision, difficulty thinking, or seizures
- chest pain
- nausea or vomiting
- shortness of breath or difficulty breathing
- unconsciousness
- slow or difficult speech
- dizziness or faintness
- weakness or numbness of an arm or leg
- hallucinating (seeing things or hearing voices that do not exist)
Patients should also carefully discuss with their doctor and pharmacist any other medications they are taking. There is potential for drug interaction complications with rasagiline. Even some foods should be avoided by patients taking rasagiline. Foods like hard salami, improperly stored meat, poultry, fish, and liver, aged cheeses, tap beer and unpasteurized beers, red wine, concentrated yeast extract, sauerkraut, and most soybean products should be avoided.
Before changing or considering changes to their treatment programs, patients should consult with their doctors and Parkinson's disease specialists.
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