Teva Pharmaceutical Industries Ltd., a leading generic pharmaceutical company, announced that Azilect (rasagiline tablets), the first once daily oral treatment for Parkinson's disease (PD) has been approved by Health Canada. The drug is approved for use as initial monotherapy in early Parkinson's disease and as adjunct therapy to levodopa in moderate to advanced disease. Azilect is expected to become available in Canada this September.
Approval for Azilect was based on data from three large, multi-centre, multinational, double-blind, randomized, placebo-controlled clinical studies. These studies in over 1,500 patients demonstrated that Azilect given once daily was effective, and well-tolerated, given as initial monotherapy in the early stages of Parkinson's disease or when added to levodopa and other therapies in more advanced stages of the disease.
"This is a key milestone for our company, but, more importantly, a significant new treatment option for the more than 100,000 Parkinson's disease patients and their families in Canada," said Jon Congleton, general manager of Teva Neuroscience Canada. "The approval of Azilect is another demonstration of Teva's continuing commitment to helping people cope with neurological diseases."
The development of Azilect is part of a long-term alliance for co-development in Parkinson's disease and European marketing between Teva and H. Lundbeck A/S. To date, Azilect has been made available in 19 countries most recently the United States in July.
Azilect is indicated for the signs and symptoms of Parkinson's disease as monotherapy and as adjunct therapy to levodopa.
Patients should not take Azilect if they have moderate to severe liver disease, have a tumour of the adrenal gland or plan to undergo elective surgery requiring general anaesthesia. Also, patients should not use Azilect if they are taking any of the following medications: antidepressants; sympathomimetic amines including amphetamines, cold medications, and weight-reducing products that contain pseudoephedrine, phenylephrine and ephedrine; cyclobenzaprine; Demerol; dextromethorphan; MAO inhibitors; pain medications and St. John's wort.
Side effects seen with Azilect alone are joint pain, indigestion; and when taken with levodopa are uncontrolled movements (dyskinesias), accidental injury, weight loss, low blood pressure when standing, vomiting, joint pain, abdominal pain, nausea, constipation, dry mouth, rash.