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|March 20, 2013 7:16 a.m.|
|New Data Show Azilect® (rasagiline tablets) Provided Clinical Benefit in Patients with Early Parkinson’s When Added to Sub-Optimally Controlled Patients on Dopamine Agonist Therapy|
Results Add to Evidence for Azilect as an Effective and Well-Tolerated Treatment Option at Different Stages of the Progression of Parkinson’s Disease (PD)
Results from the study demonstrated that the addition of Azilect 1mg/day provided a statistically significant improvement (Primary endpoint: treatment effect ± SE -2.4 ± 0.95 [95% CI -4.3,-0.5, p=0.012]) in total Unified Parkinson’s Disease Rating Scale (UPDRS) score (Parts I, II and III, version three) from baseline to week 18 in patients sub-optimally controlled with dopamine agonist monotherapy compared to placebo. Azilect was well-tolerated with no significant difference in adverse events compared to placebo.
“The positive outcome of this study is important news for the PD community, for patients and physicians,” said
As a monoamine oxidase B (MAO-B) inhibitor, Azilect acts by increasing available synaptic dopamine. This mode of action provided the rationale for add-on therapy to dopamine agonists in the management of PD.
“The ANDANTE data continue to clarify the clinical profile of Azilect and the role it plays in helping to meet the needs of those living with PD, at multiple points in the progression of their disease,” said Dr.
“We are pleased with the results of the study as they reinforce the efficacy and tolerability profile we’ve seen in the clinical development programme for Azilect,” said
Lundbeck’s long-term commitment to championing treatment advances that meet the specific needs of the CNS communities we serve, including patients, healthcare providers, care partners and advocates.”
The results of the study will be presented today as part of the Emerging Science program (formerly known as Late-Breaker Science) at the 65th
ANDANTE was an 18-week, double-blind, placebo controlled, randomized, multi-center study assessing the safety and clinical benefit of rasagiline compared to placebo as add-on therapy to stable dose of dopamine agonists (DAs) in the treatment of early PD.
In addition to the above stated primary endpoint results, data from the secondary endpoint analysis showed the addition of Azilect® resulted in a statistically significant improvement in the UPDRS motor examination subscale (Part III) (p=0.007). There were no significant differences between groups for the UPDRS activities of daily living (ADL) (p=0.301) or CGI-I scores. Azilect was well-tolerated in the study.
ANDANTE was conducted at 50 research sites in
To be enrolled patients needed to be on a stable DA monotherapy for ≥ 30 days. Patients included could not receive an optimal therapeutic dose of DAs due to intolerable side effects or were no longer experiencing sufficient control of their PD symptoms and required an additional therapeutic agent. Rescue treatment with levodopa was allowed once the patient had started treatment with study drug and had completed four weeks of treatment. DA therapy could not be adjusted during the study.
The side effect profile of Azilect as add-on to DA therapy was evaluated for changes in nature and frequency of dopaminergic adverse events.
ABOUT AZILECT® (
AZILECT® (rasagiline tablets) is indicated for the treatment of the signs and symptoms of Parkinson's disease (PD) both as initial therapy alone and to be added to levodopa later in the disease.
Patients should not take AZILECT® if they are taking meperidine, tramadol, methadone, propoxyphene, dextromethorphan, St. John’s wort, cyclobenzaprine, or other monoamine oxidase inhibitors (MAOIs), as it could result in a serious reaction. Patients should inform their physician if they are taking, or planning to take, any prescription or over-the-counter drugs, especially antidepressants and ciprofloxacin. Patients with moderate to severe liver disease should not take AZILECT®. Patients should not exceed a dose of 1 mg per day of AZILECT® in order to prevent a possibly dangerous increase in blood pressure.
Side effects seen with AZILECT® alone are flu syndrome, joint pain, depression, and indigestion; and when taken with levodopa are uncontrolled movements (dyskinesia), accidental injury, weight loss, low blood pressure when standing, vomiting, anorexia, joint pain, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, and fall.
See additional important information at http://www.azilect.com/Resources/PDFs/PrescribingInformation-pdf.aspx. For hardcopy releases, please see enclosed full prescribing information.
AZILECT® is currently available in more than 40 countries worldwide, including the U.S.,
ABOUT AZILECT® (
AZILECT® is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Hypersensitivity to the active substance or to any of the excipients. Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicinal and natural products without prescription e.g. St. John's Wort) or pethidine. At least 14 days must elapse between discontinuation of rasagiline and initiation of treatment with MAO inhibitors or pethidine. Rasagiline is contraindicated in patients with severe hepatic impairment.
Special Warnings and Precautions:
The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided. At least five weeks should elapse between discontinuation of fluoxetine and initiation of treatment with rasagiline. At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with fluoxetine or fluvoxamine. The concomitant use of rasagiline and dextromethorphan or sympathomimetics such as those present in nasal and oral decongestants or cold medicinal product containing ephedrine or pseudoephedrine is not recommended. During the clinical development program, the occurrence of cases of melanoma prompted the consideration of a possible association with rasagiline. The data collected suggests that Parkinson’s disease, and not any medicinal products in particular, is associated with a higher risk of skin cancer (not exclusively melanoma). Any suspicious skin lesion should be evaluated by a specialist. Caution should be used when initiating treatment with rasagiline in patients with mild hepatic impairment. Rasagiline use in patients with moderate hepatic impairment should be avoided. In case patients progress from mild to moderate hepatic impairment, rasagiline should be stopped.
Rasagiline must not be administered along with other MAO inhibitors (including medicinal and natural products without prescription e.g. St. John's Wort) as there may be a risk of non-selective MAO inhibition that may lead to hypertensive crisis. Serious adverse reactions have been reported with the concomitant use of pethidine and MAO inhibitors including another selective MAO-B inhibitor. The concomitant administration of rasagiline and pethidine is contraindicated. With MAO inhibitors there have been reports of medicinal product interactions with the concomitant use of sympathomimetic medicinal products. Therefore, in view of the MAO inhibitory activity of rasagiline, concomitant administration of rasagiline and sympathomimetics such as those present in nasal and oral decongestants or cold medicinal products, containing ephedrine or pseudoephedrine. Concomitant administration of rasagiline and dextromethorphan is not recommended. The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided. Serious adverse reactions have been reported with the concomitant use of SSRIs, SNRIs, tricyclic/ tetracyclic antidepressants and MAO inhibitors in clinical trials. Therefore, in view of the MAO inhibitory activity of rasagiline, antidepressants should be administered with caution.
Fertility, Pregnancy and Lactation:
No clinical data on exposed pregnancies is available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.
Monotherapy: In parentheses is the adverse reaction incidence (% of patients) in rasagiline vs. placebo, respectively. Adverse reactions with at least 2% difference over placebo are: Influenza (4.7% vs. 0.7%), depression (5.4% vs. 2%), headache (14.1% vs. 11.9%), conjunctivitis (2.7% vs. 0.7%), rhinitis (3.4% vs. 0.7%), dermatitis (2.0% vs. 0%), musculoskeletal pain (6.7% vs. 2.6%), neck pain (2.7% vs. 0%,), malaise (2% vs. 0%). Adjunct Therapy: In parentheses is the adverse reaction incidence (% of patients) in rasagiline vs. placebo, respectively. Adverse reactions with at least 2% difference over placebo are: Dyskinesia (10.5% vs. 6.2%), orthostatic hypotension (3.9% vs. 0.8%), abdominal pain (4.2% vs. 1.3%), constipation (4.2% vs. 2.1%), nausea and vomiting (8.4% vs. 6.2%), decreased weight (4.5% vs. 1.5%).
There is no specific antidote. In case of overdose, patients should be monitored and the appropriate symptomatic and supportive therapy instituted.
For further information, please consult the EU Summary of Product Characteristics or contact your local Lundbeck subsidiary.
Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with brain diseases. For this purpose, Lundbeck is engaged in the entire value chain throughout research, development, production, marketing and sales of pharmaceuticals across the world. The company’s products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy, Huntington’s, Alzheimer’s and Parkinson’s diseases. Lundbeck’s pipeline consists of several mid- to late- stage development programs.
Lundbeck employs more than 5,800 people worldwide, 2,000 of whom are based in
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This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products, competition for our innovative products, especially Copaxone® (including competition from innovative orally-administered alternatives, as well as from potential purported generic equivalents), competition for our generic products (including from other pharmaceutical companies and as a result of increased governmental pricing pressures), competition for our specialty pharmaceutical businesses, our ability to achieve expected results through our innovative R&D efforts, the effectiveness of our patents and other protections for innovative products, decreasing opportunities to obtain U.S. market exclusivity for significant new generic products, our ability to identify, consummate and successfully integrate acquisitions, the effects of increased leverage as a result of recent acquisitions, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our potential exposure to product liability claims to the extent not covered by insurance, increased government scrutiny in both the U.S. and