Daxas availability

[Everett]

The latest release. There is a lot more info in the whole press release. I have attached a copy of the press release for your review( click the little paper clip next to the smiley face if it doesn't show up)


Dear Dr Byrom


Please find below our current press release. The complete version is attached.

From Oranienburg to the rest of the world: global market launch of Daxas (Roflumilast) kicks off in Germany

- First new substance class in the area of chronic obstructive pulmonary disease (COPD) in more than a decade
- New treatment option for 700,000 patients in Germany with severe COPD and chronic bronchitis
- Improves lung function and reduces exacerbation in combination with bronchodilator treatment
- Daxas - a German success story: research and development in Konstanz; worldwide production in Oranienburg

Stefan Brinkmann, Managing Director of Nycomed GmbH, kicked off the German market launch of Daxas (Roflumilast) in Oranienburg today, making Germany the first country to market the medicine. Daxas is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that was developed by Nycomed to treat the progressive, life-threatening lung disease COPD.

Best regards

Corporate Communications
Nycomed International Management GmbH
Thurgauerstrasse 130
CH-8152 Glattpark-Opfikon
Phone +41 44 555 15 10
Fax +41 44 555 15 50

www.nycomed.com
mailto:corporatecommunications@nycomed.com

 

[jgp]

daxas in canada

Everett; i heard daxas will be available in uk and canada. could as usa doctor write a script for it? do you know anybody who would know if you don't, i know we can buy other things from there but they are fda (I dislike) approved.

 

[barbara]

My US doctor has written scripts for me that he faxed to a Canadian pharmacy. I had no problems getting my order.

 

[Bev12452]

Please let me know if you feel it is helping thanks

 

[barbara]

Not for Daxas, I meant in the past for other prescriptions.

 

[jgp]

canada and daxas

barbara; i've got scripts from there the same way, but they were approved drugs just cheaper there. daxas is not approved in usa. thats what i worry about.

 

[barbara]

Where there's a will, there's a way.

 

[Everett]

Daxas

I just got an update that DAXAS will be available in Canada the first of 2011. Forest Labs, the Nycomed US partner for distribution, also just heard back from the FDA. They are requesting more info on Daxas and didn't ask for further human trials. Typical foot dragging of the dodos. I am trying to find a source out of Germany which is where it is available now. If anyone has any connections in Germany or the pharmacies there please let m know. Thanks

 

[danny]

Forest Responds to FDA Complete Response Letter for Roflumilast

Forest Responds to FDA Complete Response Letter for Roflumilast
NEW YORK--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE: FRX) today announced that it has filed a response to the U.S. Food & Drug Administration (FDA) addressing topics raised in the complete response letter regarding the New Drug Application (NDA) for roflumilast. Forest licenses roflumilast from Nycomed, which submitted the original NDA. The FDA has acknowledged receipt of the resubmission and considers it a complete, class 2 response to their May 17, 2010 complete response letter which requested certain additional information and analyses of existing data. No additional patient trials were requested.

Roflumilast is being reviewed as a potential treatment to reduce chronic obstructive pulmonary disease (COPD) exacerbations associated with chronic bronchitis in patients at risk for exacerbations. Forest expects a response from the FDA in the first quarter of calendar year 2011.

About Roflumilast (Daxas?)

Roflumilast is a phosphodiesterase 4 (PDE4) enzyme inhibitor that targets the underlying inflammation associated with COPD. If approved, roflumilast, a once-a-day oral tablet, will be the first in a new class of treatment for COPD. Roflumilast is not a steroid.

About COPD

COPD is an under-diagnosed, progressive lung disease that is the fourth leading cause of death in the U.S., with mortality due to COPD continuing to increase in the past 30 years. Approximately 12 million people in the U.S. are currently diagnosed with COPD and an additional 14 million are likely to have the disease and not know it. Of patients diagnosed with COPD, over 80%, or 9.8 million, have COPD associated with chronic bronchitis.

Symptoms of COPD include breathlessness, chronic cough and excessive production of phlegm. A significant worsening of symptoms called an exacerbation can last several weeks and often requires substantial medical intervention, including hospitalization. Exacerbations can result in worsening health status, lung function decline, and increased risk of death.

 

[Jeannine]

Sort of leaves us in suspense about what the FDA will do next?

 

[Everett]

FDA dummies

YOu mean besides aggrivate the people that they are supposed to serve-the public- not the big drug companies that line their pockets?

 

[jgp]

efforts letter about daxas

on saturday a german women posted on efforts. she said she been using for over 2months her doctor watching close, she claims a 6 point gain in her fev1 and no side effects yet. but she said others also improved but had some side effects.

 

[barbara]

I wonder if the side effects were any worse than exacerbations, shortness of breath and all the other great things that go with this disease!

 

[jgp]

why wait till fev1 is less than 50%

they say daxas should be used on people with fev1 post-brochodilator less than 50%. why? the great part of this drug is that pde4 inhibitor slows inflammation of lungs which is suppose to slow progression,why wouldn't you try to stop progression as soon as posible. maybe it's just me? but i think start as soon as possible.

 

[barbara]

The FDA in the U.S. says Daxas is dangerous and we shouldn't use it at all. That tells me how much they know. I agree with your thinking. Why wait to deteriorate even more.

 

[jgp]

daxas in canada

daxas is supposed to be sold in canada by 2011. but i would love to find out if someone with a fev 1 greater than 50% can get it? from what i've read the few isde effects go away afterwhile. anybody out there know?

 

[Jeannine]

I would think your doctor would be able to decide if it's right for you. I can't see why you have to get worse before you can use it? Makes no sense.

 

[Everett]

DAXAS in Canada

JGP
I have gotten Spiriva before it was approve here in the states by the YAHOO Bunch. I dont see any problem with it. I am trying to find a pharmacy in Germany that can fill my script for it now. Anyone know of one?