What is Azilect?
Azilect is a medicine that contains the active substance rasagiline, available as white, round tablets (1 mg).
What is Azilect used for?
Azilect is indicated for the treatment of Parkinson's disease. Parkinson's disease is a progressive mental disorder that causes tremor, slowness of movement and muscle stiffness. Azilect can be used on its own (as a single agent) or as a combination therapy with levodopa (another medicine used to treat Parkinson's disease) in patients with end-of-dose "fluctuations" in the time interval between the different administrations of doses of levodopa. The fluctuations are linked to a reduction in the effects of levodopa, during which the patient is subjected to sudden changes between the "on" state, in which he is able to move, and the "off" state, ie immobility. Azilect can only be obtained with a prescription.
How is Azilect used?
The standard dose of Azilect is one tablet once a day, to be taken with or without food.
How does Azilect work?
The active substance in Azilect, rasagiline, is a "monoamine oxidase-B" inhibitor. It blocks the enzyme monoamine oxidase type B, which is responsible for the degradation of the dopamine neurotransmitter in the brain. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. In patients with Parkinson's disease, dopamine-producing cells begin to die, resulting in a decrease in the amount of this neurotransmitter in the brain. Patients therefore lose the ability to control their movements reliably. By increasing dopamine concentrations in the brain areas responsible for movement and coordination, Azilect improves the signs and symptoms of Parkinson's disease such as stiffness and slowness of movement.
How has Azilect been studied?
Azilect has been studied in three main studies involving a total of 1, 563 patients with Parkinson's disease. In the first study, the effects of two different doses of Azilect taken as monotherapy were compared with those of placebo (a dummy treatment) in 404 patients at the early stage of the disease. The main measure of effectiveness was the change in symptoms over 26 weeks, measured according to a standard assessment scale ( Unified Parkinson's Disease Rating Scale, UPDRS).
The other two studies were conducted in total on 1 159 patients with the disease at a more advanced stage, in which Azilect was added in association with the ongoing therapy of the patient comprising levodopa. The drug was compared with placebo or with entacapone (another medicine used to treat Parkinson's disease) . The studies lasted 26 and 18 weeks, respectively. The main measure of effectiveness was the time spent in the "off" state during the day, as reported in the patient journals.
What benefit has Azilect shown during the studies?
In all studies, Azilect was more effective than placebo. In the study in which Azilect was used on its own, patients who took 1 mg of the medicine once a day reported an average UPDRS score reduction of 0.13 points over the 26 weeks of study compared to starting value of 24.69. This result should be compared with the increase of 4.07 points registered among subjects treated with placebo, whose starting value was 24.54. A reduction in the UPDRS score indicates an improvement in symptoms, while an increase indicates worsening. When used in combination with levodopa, 1 mg of Azilect reduced the "off" state time more than placebo. In both studies, patients who took Azilect as adjunctive therapy reported, on average, about an hour less in the "off" state than those on placebo. A similar reduction in time spent in the "off" state was observed in subjects treated with entacapone.
What is the risk associated with Azilect?
The most common side effect of Azilect (seen in more than 1 patient in 10) is headache. For the full list of all side effects reported with Azilect, see the Package Leaflet. Azilect should not be used in people who may be hypersensitive (allergic) to rasagiline or any of the other ingredients. Azilect should not be used with other monoamine oxidase inhibitors such as medicines or herbal preparations without a prescription such as St. John's wort. Azilect should not be used with pethidine (a pain reliever). At least 14 days must elapse between stopping treatment with Azilect and starting treatment with another monoamine oxidase inhibitor or pethidine. Azilect must also not be given to patients with severe liver problems. It is not recommended in patients with moderate liver problems. Patients with mild liver problems should take Azilect with caution and should stop treatment if their liver problems worsen.
Why has Azilect been approved?
The Committee for Medicinal Products for Human Use (CHMP) has determined that the benefits of Azilect outweigh its risks for the treatment of Parkinson's disease both as monotherapy (without levodopa) and as a combination therapy (with levodopa) in patients with fluctuations at the end of the dose. The Committee therefore recommended that Azilect be given marketing authorization.
More information on Azilect:
On 21 February 2005, the European Commission issued a marketing authorization valid for Azilect to Teva Pharma GmbH, valid throughout the European Union. The marketing authorization was renewed on 21 February 2010.
The full EPAR for Azilect can be found here.
Last update of this summary: 02-2010.
