Teva wins US approval for Parkinson's drug Azilect

http://www.rasagiline.com/azilect-usa.html

Israeli drugmaker Teva Pharmaceuticals, currently the biggest generic pharmaceuticals firm in the world, got a boost for its proprietary business yesterday after winning approval in the USA for Azilect, the first once-daily oral treatment for Parkinson's disease.

The US Food and Drug Administration (FDA) cleared Azilect (rasagiline) as initial monotherapy in early-stage Parkinson's, as well as in combination with the standard drug levodopa for more advanced cases of the disease. Teva said it would launch the product within the next eight to 10 weeks.

Azilect hit a few hurdles on the way to US approval, with the Food and Drug Administration (FDA) asking for additional data on the drug in August 2005, but is already on the market in Europe and under regulatory review in Canada.

In a statement following the approval, the FDA noted that an increase in skin cancer has been observed in patients involved in the Azilect trials, but there is no evidence to directly link the drug to these cases.

"It appears that compared to the general population, patients with Parkinson's disease have an increased risk for this form of skin cancer," said the agency. Teva has agreed to carry out a post-marketing study of Azilect in order to address the question of whether or not the drug increases this risk. Meanwhile, the Israeli company is also conducting a large clinical study - called ADAGIO - to see whether Azilect can slow the progression of Parkinson's disease.

Azilect is Teva's second proprietary drug after Copaxone (glatiramer acetate) for multiple sclerosis, and the company has doubled the salesforce at its Teva neuroscience marketing subsidiary on Copaxone's stellar growth and in anticipation of the addition of Azilect to its stable.

The development of Azilect is part of a long-term alliance for co-development in Parkinson's disease and European marketing between Lundbeck and Teva. In the three major European markets, the UK, Germany and France Teva and Lundbeck co-promote Azilect. In the USA, Teva has an agreement to co-promote the drug with Eisai, although no decision on this has yet been taken.

Azilect is a second-generation selective irreversible monoamine oxidase type B (MAO-B) inhibitor that blocks the breakdown of dopamine, a substance in the brain needed to facilitate movement.

Parkinson's disease is a chronic, progressive, neurodegenerative disorder whose exact cause remains unknown. It is estimated that around 1.5 million people in the USA suffer from PD and, in 2005, global sales of drugs to treat the condition were about $3 billion.

"Parkinson's is a relentless disease with limited treatment options, and each new therapy is an important addition to the physicians' treatment options," said Steven Galson, head of the FDA's Center for Drug Evaluation and Research.

My words below are NOT meant to alarm, but to make sure that anyone considering this medication is aware of the conditions regarding this med...so that you can have an educated discussion with your doctor about the med.

Before considering taking Azilect, be sure to...review

1)"important safety information" (see URLs below) regarding banned foods..."Foods that are high in tyramine include aged cheeses, dried meats, sausage, hard meats, improperly stored meats, red wine, beer, herring, fava beans, yeast, sauerkraut, and soybean products such as soy sauce or tofu."

and

2) the fact that this is a MAO type B (MAO-B) inhibitor,

and

3) there are some medciations that you might already be taking that you will have to stop taking; e.g. certain anti-depressants.

and consider

4) purchasing a braclet (I wear a MedicAlert bracelet) that carries the "alert" that you are taking a MAO=B inhibitor for Parkinson's disease...as I would always recommend for any MAO inhibitor or medication that has interactions with other medications; e.g. anesthesia.

See:
http://www.azilect.com/comingsoon/
and
http://www.drugs.com/azilect.html

or another Internet reference about Azilect

husband's physician and the TEVA pharmacist with whom I spoke about food restrictions and rasagiline both maintain that as long as one does not exceed the 2 mgm/day dosage of Azilect, there are no restrictions of tyramine foods. only when one inhibits MAO-A receptors must one worry about tyramine.
and the increased incidence of skin cancer in PD patients was mentioned in the initial literature I read about PD--there were several old inquiries into the dysfunction of neuromelanin and melanin in PD. the research must have not been fruitful--no mention of any of those studies in quite a while. in the meantime, husband gets checked by a dermatologist yearly. if it's not one thing, it's another.
interesting that Dr. Youdim who spoke about rasagiline at the WPC in Feb maintained that one must inhibit both MAO-A and B receptors to affect any changes in Dopamine levels--that the reason rasagiline works is because of a molecule "propargylamine"--not because of its effect upon dopamine levels .
anyone know how to contact CS3???he would know about this. I miss his postings, and am concerned because he was dealing with a major illness in his wife as well as his own PD. does anyone have his email address? I would like to know how he is doing. thanks, madelyn

I've been on azilect for 3 weeks now. Thanks to Carolyn for her warning, i now wear a medic alert bracelet!

i've titrated down to .25 mirapex 2 or 3 X a day. Stalevo 2X a day.

what i noticed today is in the past 3 weeks, i have had NO episodes of neuropathic pain. this is a very good thing as anyone who suffers from neuropathic pain (burning - shooting pain to your nerve endings) knows.

jean