Thank you very much Kristin, for posting this.  Very useful information for
those of us who have Azilect in our lives.  Prem is going to be delighted
that his diet need not be quite so restricted - as will I because my diet is
the same as his to make my life simpler.  :-)
Moneesha



2010/1/7 Kristin Woestehoff <[log in to unmask]>

>
> Teva Pharmaceutical
> Ifound this interesting.  Kristin
>
>
>
> Teva Pharmaceuticals today announced the FDA approved newly revised
> prescribing information for AZILECT® (rasagiline tablets) reducing certain
> food and medication restrictions. This update was based on clinical data
> that showed AZILECT® is a selective MAO-B (monoamine oxidase-B) inhibitor at
> recommended doses.
>
> For patients taking AZILECT®, this means they no longer need to follow a
> restriction ofordinary levels ofdietary tyramine.  Tyramine is an amino acid
> found in certain foods and beverages, including some air-dried and fermented
> meats, some aged cheeses and most soybean products.  Non-selective monoamine
> oxidase (MAO) inhibitors interfere with the breakdown and elimination
> oftyramine from the body, which can cause a serious increase in blood
> pressure.
>
> In addition, the FDA-approved prescribing information reflects reduced
> concerns about the use ofAZILECT® in combination with aminescontained in
> medications, including many over-the-counter cough and cold medicines.
>
> Please find the full press release below.
>
> Michele Popadynec, RN
> Associate Director ofScientific
> & Medical Affairs
> American Parkinson Disease Association
> 135 Parkinson Avenue
> Staten Island, NY10305
> Phone: 1 800 223-2732 ext. 118
>
>
> +++++++++++++++++++++++++++++++++++++++++++
> Business Wire
> “FDA Approves Newly Revised Prescribing Information for AZILECT® Reducing
> Medication and Food Restrictions”
> December 14, 2009
> Teva Pharmaceutical Industries, Ltd. (NASDAQ: TEVA) today announced the
> U.S. Food and Drug Administration (FDA) approved the newly revised
> prescribing information for AZILECT® (rasagiline tablets) reducing
> medication and food restrictions. This update was based on clinical data
> that confirmed the mechanism of action of AZILECT® as a selective MAO-B
> (monoamine oxidase-B) inhibitor at the recommended doses of 1 mg and 0.5 mg.
> The newly approved prescribing information reflects reduced concerns
> regarding the use of AZILECT® together with certain medications, including
> many over-the-counter cough/cold medications. In addition, patients taking
> AZILECT® no longer need to follow a general dietary restriction of ordinary
> levels of tyramine, an amino acid found in certain foods and beverages, such
> as air-dried and fermented meats, aged cheeses and most soybean products.
> However, due to potential mild increased sensitivity in some patients,
> ingestion of very high levels of tyramine (e.g., >150 mg) should be avoided
> by patients taking MAO inhibitors.
> “The FDA’s decision to modify the AZILECT® prescribing information
> emphasizes the benefit to patients of AZILECT® MAO-B selectivity at
> recommended doses,” said Daniel Kremens, M.D., Assistant Professor of
> Neurology and Co-Director of the Parkinson’s Disease and Movement Disorders
> Division at Jefferson Medical College of Thomas Jefferson University in
> Philadelphia. “This is good news for patients and physicians as it
> reconfirms the safety and convenience of AZILECT®.”
> “We are pleased with this important change in the prescribing information
> of AZILECT® as it removes a barrier for some physicians, and some patients,
> living with Parkinson’s disease,” said Jon Congleton, VP and General
> Manager, U.S., Teva Neuroscience. “Physicians can now better focus on what
> is really most important, which is helping patients receive a proven
> efficacious and safe treatment, at diagnosis early in Parkinson’s disease,
> and throughout the course of the disease.”
> About the Tyramine Study
> The tyramine study, submitted to the FDA as the basis for the change in the
> prescribing information, supported the selectivity of AZILECT® for
> inhibition of MAO-B at approved doses, 1 mg and 0.5 mg. Non selective MAO
> inhibitors may interfere with the breakdown and elimination of tyramine in
> the body, which can induce hypertensive reactions.
> The tyramine study was a double-blind, placebo-controlled, randomized,
> dose-ranging study of rasagiline using a positive control (phenelzine), a
> known non-selective MAO inhibitor, and a comparator drug (selegiline). This
> study was part of a Phase IV commitment to the FDA at the time of AZILECT®
> approval. The study results were based on Tyramine Sensitivity Factor (TSF),
> which measures the ratio of tyramine pressor dose before (baseline) and
> after MAO inhibitor administration.
> In the study, 179 healthy male and female volunteers, aged 40 to 70 years
> received escalating doses of oral tyramine from 25 mg up to 800 mg
> administered under fasting conditions. TSF was calculated as the tyramine
> dose associated with three consecutive increases from baseline in systolic
> blood pressure (SBP) 30 mm Hg over 10 minutes (tyramine pressor dose) in
> period one divided by the dose associated with the same change in SBP in
> period three.
> Geometric mean TSFs of all doses of rasagiline were substantially lower
> than the TSF for phenelzine. TSFs of various doses of rasagiline were
> comparable to those of selegiline and placebo.
> About AZILECT®
> AZILECT® (rasagiline tablets) is indicated for the treatment of the signs
> and symptoms of Parkinson’s disease (PD) as initial therapy alone and to be
> added to levodopa later in the disease.
> AZILECT® is now available in 39 countries, including the U.S., Canada,
> Israel, Mexicoand all of the European Union countries, where it is marketed
> by Teva in collaboration with Lundbeck A/S as part of a long-term strategic
> alliance.
> 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 five million people worldwide suffer from the disease,
> with an average age of onset of about 60 years.
> About Teva
> Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in
> Israel, is among the top 20 pharmaceutical companies in the world and is the
> leading generic pharmaceutical company. The company develops, manufactures
> and markets generic and innovative pharmaceuticals and active pharmaceutical
> ingredients. Over 80 percent of Teva’s sales are in North Americaand Western
> Europe.
> Teva’s SafeHarborStatement 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 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 successfully develop
> and commercialize additional pharmaceutical products, the introduction of
> competing generic equivalents, the extent to which we may obtain U.S. market
> exclusivity for certain of our new generic products and regulatory changes
> that may prevent us from utilizing exclusivity periods, potential liability
> for sales of generic products prior to a final resolution of outstanding
> patent
>  litigation, including that relating to the generic versions of Neurontin®,
> Lotrel®, Protonix® and Eloxatin®, the current economic conditions,
> 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 effects of competition on our innovative products,
> especially Copaxone® sales, dependence on the effectiveness of our patents
> and other protections for innovative products, the impact of consolidation
> of our distributors and customers, the impact of pharmaceutical industry
> regulation and pending legislation that could affect the pharmaceutical
> industry, our ability to achieve expected results though our innovative R&D
> efforts, the difficulty of predicting U.S. Food and Drug Administration,
> European Medicines Agency and other regulatory authority approvals, the
> uncertainty surrounding the legislative and regulatory pathway for the
>  registration and approval of biotechnology-based products, the regulatory
> environment and changes in the health policies and structures of various
> countries, supply interruptions or delays that could result from the complex
> manufacturing of our products and our global supply chain, our ability to
> successfully identify, consummate and integrate acquisitions, the potential
> exposure to product liability claims to the extent not covered by insurance,
> our exposure to fluctuations in currency, exchange and interest rates,
> significant operations worldwide that may be adversely affected by
> terrorism, political or economical instability or major hostilities, our
> ability to enter into patent litigation settlements and the intensified
> scrutiny by the U.S. government, the termination or expiration of
> governmental programs and tax benefits, impairment of intangible assets and
> goodwill, environmental risks, and other factors that are discussed in this
> report and in
>  our other filings with the U.S. Securities and Exchange Commission
> (”SEC”).
> Press Release Contact Details:
> Teva Pharmaceutical Industries Ltd. Elana Holzman, 972 (3) 926-7554 or Teva
> North America Kevin Mannix, 215-591-8912 www.tevapharm.com
>
>
>
>
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