ADVAIR (FROM C I )

[morningstar]

Thought this might be of a interest to some of you that use this. I don't . I found the link on C I and carried it over.

www.forbes.com/feeds/ap/2007/08/08/ap3999652.html

[Blossom/Jackie W.]

Thanks Rose......Anyone on Advair here?

Also; I read the piece......now get this guys as to what was partial written ......"The Food and Drug Administration told the company in a letter that the inhalable medication is "not approvable" for patients with chronic obstructive pulmonary disease, a lung disorder which can cause bronchitis and emphysema"

Can you believe that? According to this ......COPD can casue bronchitis & emphysema.....
Sheeeesh....this piece is from Forbes no less....

[John]

I'm on advair and it works pretty good in my case And I have copd. Are we all on the same page ? Sometimes it gets a little scary out there When one reads articles written like this one Where did that the person from the FDA go to school & I'm not to comfortable with their sources

[the bear]

I am on Advair also. There seems to be some confusion here on the delivery of the medication and the dosage.

I was in contact with Mark Mangus respiroligist at Efforts and he did not know what I was talking about. In Canada and other places I assume the Advair I use comes in a little puffer that contains a premeasured, metered dose of 125/25mcg of the medication salmeterol xinafoate/fluticasone propionate.

Just the name is enough to scare you.

But the basic difference is the delivery system.

The metered dose of 125/25mcg you have to count as there is 120 metered doses. If you use two puffs twice a day that is four per day divided into 120 means it will last 30 days. I use 4 puffs daily but have 1 for day use and one for night use so I get 60 days using both.

The diskus gives a bigger dose, and as I sent my disc to Mark I do not know the dosage for sure, but if my memory serves me it is about twice the dosage and the advantage is that it has a counter that counts down from 60 to 0 so you know when you are getting low.

Hope this did not muddy the waters but help to clarify that the problem may not be with the medication but with the dosage that is inhaled. Hugz, as ever, bear. ;D ;D

[maryaz]

Bear. My purpose for posting here is that maybe I can provide you some info and save some searching regarding the Advairs. August 8th I posted the following elsewhere:

Wow! I am surprised at this really, but then I am not either. I have a lot I could say but better if I just let it go. There is a bill or something floating around concerning the coverage of 'off label' drugs. This would hurt many people if that were in effect. Grrrrr

COPD :: GSK receives decision from FDA on Advair 500/50 for COPD
GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the supplemental drug application for the 500/50 strength of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in the treatment of patients with chronic obstructive pulmonary disease (COPD).

The FDA questioned how Advair 500/50 compared to the currently approved 250/50 strength in order to allow for appropriate dosing recommendations. GSK will be meeting with FDA to discuss this request in more detail and determine next steps, including discussion of data GSK has recently generated on the reduction of exacerbations with the Advair-250/50strength.

“We are very surprised and disappointed by this FDA decision particularly given the outcome of the FDA advisory committee meeting earlier this year,” said Katharine Knobil, M.D., Vice-President of Respiratory Clinical Development for COPD at GSK. “The advisory committee voted unanimously that Advair 500/50 demonstrated a significant reduction in the risk of exacerbations. We believe in the strength of the data; this application is based on the results of the largest COPD study conducted in more than 6,000 patients over three years. We are committed to working with the FDA to address any questions they have and to pursue a way forward.”

www.spiritindia.com/health-care-news-articles-12094.html

The following was provided to me after my post.

I was interested in this "not approvable letter" so I looked up the appropriate Code of Federal Regulations - Title 21 to see what that meant. Here it is:

"(d) Not approvable letter. FDA will send the applicant a not approvable letter if the agency believes that the application may not be approved for one or more of the reasons given in 814.118. The not approvable letter will describe the deficiencies in the application and, where practical, will identify measures required to place the HDE in approvable form. The applicant may respond to the not approvable letter in the same manner as permitted for not approvable letters for PMA's under 814.44(f), with the exception that if a major HDE amendment is submitted, the review period may be extended up to 75 days."

So, that means the application, for some reason, did not meet their requirements and is not approvable in its present state, and the applicant can respond with the additional required information. The use of Advair 500/50 for COPD has NOT been disapproved pending the submission of additional information. You have to be careful with these government docs...the wording is NOT casual.

The last I read the 500/50 was not yet approved. I use 500/50 and with an off label enforcement that would not work for me.

I have conversed with Mark Mangus before. When I first found his webpage. Some like him and some don't. I found him to be very nice. Some people got upset over reading this webpage but it needs to be kept in mind that this is just the opinion of one person, namely Mark Mangus, RTT. Mark has added some in the Albuterol area that I sure never heard of and hope I don't. I get confused enough with the few I use. The order of sequence has never been studied and so anyone can determine what might work.
www.emphysema.net/inhaler_sequence.htm

I am surprised he didn't know about the Advair HFA. Here is an article that I had on it from last year. I had forgotten about this article. People are mentioning trying this Advair HFA Inhaler now:
www.medicalnewstoday.com/articles/54393.php

I will personally add to this by saying that some people have a harder time drawing in from the Advair Diskus than they would using an Inhaler. Personal preference I can understand. New methods of delivery just to keep a medicine from going generic I cannot accept. Advair has been a big winner for GSK and soon to go generic. All our new HFA inhalers are higher priced than the old ones.

My concern, of recent, has been symbicort and now that I re-read about the Advair here, I guess that is why the symbicort in the USA is so different from Europe and Canada. It has gone from numbers like 400/12, 200/12 to something like 80/4.5.

I am with Jackie about some of the poorly written article on COPD. Such a shame because we have enough negative to overcome without bad writers that do not know what they are talking about. I have read 2 good articles this year though.

I don't generally post the US stuff here too much because most of you are in Canada so far. When I read your post today, I thought I would share.

[Blossom/Jackie W.]

Thanks for all the homework you did on this one Mary. It was extensive and certainly very much appreciated.

[the bear]

Well said Mary and thanks so much for chiming in. That is what this forum is for. As a member of efforts too I am quite familiar with Mark and his excellent contributions to efforts. He simply did not know what I was refering to in my posts on Advair. The discus delivers 250/50 so is twice the dosage of our 125/25.
To my knowledge only the 125/25 has been approved in Canada.
If GSK wants to keep changing the dosage, would they have to get approval from the FDA everytime??
Sometimes I think our drug approval processes are too slow and then I remember thalidomide and all the damage it did. Hugz, bear.