KANSAS CITY, Mo., June 8 /PRNewswire-FirstCall/ -- New information on the use of AZILECT(R) (rasagiline tablets) for the treatment of Parkinson's disease (PD) was reported this week at The Movement Disorder Society's congress in Istanbul, Turkey. Once-daily AZILECT was approved by the FDA May 17, 2006, for the treatment of the signs and symptoms of PD, both as initial monotherapy and as adjunct therapy to levodopa.
AZILECT(R) Monotherapy Demonstrates Benefits in Early PD Regardless of Disease Duration
Dr. John Bertoni, M.D., Ph.D., Creighton University provided the results of a new post-hoc analysis of the 26-week, multicenter, randomized, double-blind TEMPO study, that included 404 patients who received once-daily AZILECT 1mg, 2mg, or placebo. This analysis revealed that AZILECT once-daily as monotherapy provided a consistent beneficial effect on the symptoms of PD regardless of the duration of the disease at the time treatment was started. AZILECT 1 mg/day significantly improved UPDRS-Total score compared to placebo in both the < 1-year stratum (-0.52 vs 3.33; p<0.001) and the greater than or equal to 1-year stratum (0.81 vs 4.76; p<0.01). "The time to diagnosis and initial treatment is different for every patient," said Dr. Bertoni. "Demonstrating that AZILECT monotherapy has a beneficial effect, regardless of disease duration, is important when considering it as a treatment option for patients with PD."
AZILECT(R) Clinical Experience When Given Concomitantly with Antidepressants
Dr. Michel Panisset, M.D., CHUM - Hotel-Dieu de Montreal, Quebec, reported on an evaluation of the records of 1,361 patients who had taken AZILECT for the treatment of Parkinson's disease in controlled clinical trials to assess the safety of combining antidepressant therapy with AZILECT. Three hundred and twenty three (323) of the total 1,361 patients (24%) were noted to have taken a concomitant antidepressant, including amitriptyline, sertraline, paroxetine, trazodone, and citalopram. No apparent cases of serotonin toxicity (ST) occurred. Symptoms that occurred more frequently with the combination of AZILECT plus antidepressant could be accounted for as being symptoms of either antidepressant use or of depression.
"Rates of termination of treatment were similar, with and without antidepressants, further supporting the relative safety of AZILECT(R) (rasagiline tablets) combined with antidepressants," said Dr. Panisset. "Twenty four percent of the total number of AZILECT treated PD patients were also taking antidepressants. Seeing this apparent lack of serotonin toxicity is important."
According to the US prescribing information the exposure during development, both in dose and number of subjects was not adequate to rule out the possibility of an untoward reaction from combining AZILECT with antidepressants. Other MAO-B inhibitors are labeled similarly.
AZILECT 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. The effectiveness of AZILECT was shown in patients with early PD who were receiving AZILECT as initial therapy alone and who were not receiving any other PD therapy. The effectiveness of AZILECT as adjunct therapy was shown in patients with PD who were treated with levodopa.
-- You should not take AZILECT if you are currently taking meperidine as
it could possibly result in a serious reaction such as coma or death.
-- You should not take AZILECT with tramadol, methadone, propoxyphene,
dextromethorphan, St. John's wort, mirtazapine, or cyclobenzaprine.
-- You should not take AZILECT with other monoamine oxidase inhibitors
(MAOIs), amphetamines, cold remedies containing decongestants and
weight-reducing preparations containing pseudoephedrine, phenylephrine,
phenylpropanolamine, or ephedrine in order to avoid a possibly
dangerous increase in blood pressure. Symptoms of this reaction include
severe headache, blurred vision, difficulty thinking, seizures, chest
pain, unexplained nausea or vomiting, or signs or symptoms of a stroke.
You or your caregiver should seek immediate medical attention if these
symptoms or other unusual symptoms occur.
-- In order to prevent a possibly dangerous increase in blood pressure,
when taking AZILECT you should avoid foods and beverages high in
tyramine content such as aged cheeses, air-dried meats, pickled
herring, yeast extract, aged red wines, tap/draft beers, sauerkraut,
and soy sauce.
-- When taking AZILECT, you should not have elective surgery requiring
general anesthesia, and should not receive cocaine or other local
anesthesia that contains ingredients that could raise blood pressure.
-- You should inform your physician if you are taking, or planning to
take, any prescription or over-the-counter drugs, especially
antidepressants and ciprofloxacin.
-- If you have moderate to severe liver disease or a tumor of the adrenal
gland, you should not take AZILECT.
-- All PD patients are advised to monitor for melanoma (skin cancer)
frequently and see a dermatologist on a regular basis.
Side effects seen with AZILECT alone are headache, joint pain and indigestion; and when taken with levodopa are uncontrolled movements (dyskinesias), accidental injury, nausea, weight loss, constipation, low blood pressure when standing, joint pain, vomiting, dry mouth, rash, and sleepiness. Be sure to tell your doctor about these and any other side effects you experience when taking AZILECT.
About Parkinson's Disease
Parkinson's disease is an age-related degenerative disorder of the brain. Symptoms can include tremor, stiffness, slowness of movement, and impaired balance. An estimated 1 million Americans have the disease, which usually affects people over the age of 60.
Teva Pharmaceutical Industries Ltd. , headquartered in Israel, is among the top 20 pharmaceutical companies in the world. The company develops, manufactures, and markets innovative and generic human pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Europe. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.
Teva's U.S. innovative product marketing subsidiary, Teva Neuroscience, Inc., promotes AZILECT in the United States. AZILECT is a registered trademark of Teva Pharmaceutical Industries Ltd.
Please visit http://www.AZILECT.com for additional important information.
Please see enclosed additional important information.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: 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 Teva's 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: Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which Teva may obtain U.S. market exclusivity for certain of its new generic products and regulatory changes that may prevent Teva from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra(R) and Neurontin(R), the effects of competition on our innovative products, especially Copaxone(R) sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Teva Neuroscience, Inc.