my personal edition > parkinson's > news


  E-Mail this DGNews to a colleague

DGNews

Azilect (Rasagiline Tablets) Now Available in Pharmacies

First, Once-Daily Treatment for Parkinson's Disease

KANSAS CITY, MO -- July 31, 2006 -- Teva Neuroscience announced today the launch of Azilect(R) (rasagiline tablets), the first, once-daily treatment for Parkinson's disease (PD) now available in pharmacies by prescription only. This is important news for the majority (83%) of respondents in a survey of those living with PD who report taking their PD medications up to five times/day.

Azilect(R) is indicated for use as initial monotherapy in early PD and as adjunct therapy to levodopa in moderate-to-advanced disease. Based on survey results of 276 persons living with PD, Teva has created the PD Exercise Kit in conjunction with the launch of Azilect(R).

Teva is committed to providing resources that can help people effectively manage PD. The Kit includes information on the availability of once-daily Azilect(R), an online fitness tracker, and PD-specific exercise options created by actress and health and fitness guru Marilu Henner. The company is also offering the Azilect(R) My Exercise Contest with the opportunity to win a trip to the Parkinson's Unity Walk.

"Azilect(R) provides physicians and people living with PD another treatment option to help control the symptoms of Parkinson's disease. Azilect(R) (rasagiline tablets) is well tolerated and offers convenient dosing, making it a good choice for people living with PD in both early and moderate-to-advanced stages of the disease," said Larry Downey, president and chief executive officer of Teva Neuroscience, Inc. "Consumers and caregivers are becoming more proactive in disease management, so we believe it is critical to provide them with tools and resources in addition to Azilect(R)."

Azilect(R) was approved by the Food & Drug Administration May 17, 2006, based on data from three multicenter, multinational, double-blind, randomized, placebo-controlled, clinical studies. The studies, which included more than 1,500 patients, provided statistically significant evidence of efficacy, while also demonstrating good tolerability as both initial monotherapy in early disease and adjunct therapy in moderate-to-advanced disease.

A survey of 276 people living with PD confirmed that they have many treatment options for PD.

Teva Neuroscience believes that Azilect(R) will help patients manage symptoms of PD. In addition, the survey respondents reported that they are not well connected with on-line PD resources or with others living with the disease. Some are also interested in sharing their first-hand accounts of what it is like to live with PD. Some people living with PD say there is a benefit to exercise when paired with the right drug treatment, on symptom control.

"The launch of Azilect(R) is exciting for physicians, their patients, and caregivers living with PD," said Dr. Warren Olanow, professor and chairman of the Department of Neurology at Mount Sinai School of Medicine. "Azilect(R)'s availability and the PD Exercise Kit are new tools to help people living with PD better manage their disease."

"The convenience of once-daily dosing and the flexibility of use as monotherapy in early disease or as adjunct therapy to levodopa makes Azilect(R) a good treatment option for those living with PD."

Azilect(R) (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. 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.

-- Patients should not take Azilect if they are currently taking meperidine as it could possibly result in a serious reaction such as coma or death.

-- Patients should not take Azilect with tramadol, methadone, propoxyphene, dextromethorphan, St. John's wort, mirtazapine, or cyclobenzaprine.

-- Patients 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. Patients or caregivers should seek immediate medical attention if these symptoms or other unusual symptoms occur.

-- In order to prevent a possibly dangerous increase in blood pressure, patients taking Azilect 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.

-- Patients taking Azilect 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.

-- 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 or a tumor of the adrenal gland 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 (rasagiline tablets) 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. Patients should tell their doctor about these and any other side effects they experience when taking Azilect.

Parkinson's disease is a degenerative disorder of the brain. Symptoms can include tremor, stiffness, slowness of movement, and impaired balance. An estimated one million Americans have the disease, which usually affects people over the age of 60.


SOURCE: Teva Neuroscience

E-Mail this DGNews to a colleague

To print, use this version