Letter From Shire - Proamatine Discontinued - September 2010

[iheartcats]

My message directly from Shire says they will be discontinuing ProAmatine in September 2010 as a business decision. It goes on to say they are sorry if it is affecting my treatment plans.

Does this mean generics will be discontinued, also?

I am having an anxiety attack.

You can contact them here: medinfoglobal@shire.com

[shanying418]

My message directly from Shire says they will be discontinuing ProAmatine in September 2010 as a business decision. It goes on to say they are sorry if it is affecting my treatment plans.

Does this mean generics will be discontinued, also?

I am having an anxiety attack.

You can contact them here: medinfoglobal@shire.com

Would you mind posting their original message--the one saying that they are discontinuing ProAmatine-- here? Or can you send me a private message if you don't mind? I think I want to talk to my doctor about this... Tks.

[iheartcats]

My message directly from Shire says they will be discontinuing ProAmatine in September 2010 as a business decision. It goes on to say they are sorry if it is affecting my treatment plans.

Does this mean generics will be discontinued, also?

I am having an anxiety attack.

You can contact them here: medinfoglobal@shire.com

Would you mind posting their original message--the one saying that they are discontinuing ProAmatine-- here? Or can you send me a private message if you don't mind? I think I want to talk to my doctor about this... Tks.

The PDF they sent doesn't allow copy and paste. I will type it out later tonight or in the morning for everyone.

[emadden514]

I really hope this isn't the case. I just started taking it and it's working.

Elizabeth

[firewatcher]

I've seen several business and pharmacy blogs about this. This is one of the business blogs from today:

On Monday, the US Food and Drug Administration announced a proposition to pull ProAmitine (Midodrine) from the market due to Shire (SHPGY) not conducting post-approval studies to prove that the drug has a benefit.

Midodrine is currently the only FDA-approved drug for Orthostatic Hypotension. It was approved in 1996 as part of a shorter approval process under the condition that Shire conduct post-approval studies. Midodrine never was a big seller for Shire, and post-approval studies were never conducted. Midodrine was bringing in around $60M/yr as of 2005. FDA stated that around 100,000 patients filled prescriptions for brand or generic Midodrine in 2009. Take note that if the FDA withdraws the medicine's approval, generic companies including Mylan Pharmaceuticals (MYL), Impax Laboratories (IPXL), and Novartis (NVS) unit Sandoz must stop selling their generic versions of Midodrine.

The company that benefits from this decision is Chelsea Therapeutics (CHTP). Chelsea is developing Northera (droxidopa) for the treatment of Orthostatic Hypotension, with pivotal phase 3 trial results due in September.

Furthermore in Chelsea?s favor, Needham & Co analyst Alan Carr said the FDA action could help:

"The potential removal of midodrine may create a greater market opportunity for Droxidopa in the U.S.," said Carr in a research note.

If Midodrine is removed from the market, and Chelsea?s Northera study (Study 302) succeeds, the stock should most definitely be higher than it is now (if stock price rises to market potential, $6-$7 is very possible).

There is a lot of chatter and several news articles about dwindling supplies for dialysis patients and nursing homes. I don't think stockpiling is going to help.

[Noreen]

My message directly from Shire says they will be discontinuing ProAmatine in September 2010 as a business decision. It goes on to say they are sorry if it is affecting my treatment plans.

Does this mean generics will be discontinued, also?

I am having an anxiety attack.

You can contact them here: medinfoglobal@shire.com

Anxiety attack here too.

A literature review article cites the efficacy of midodrine and bases some conclusions on unpublished data provided by Shire.

http://ndt.oxfordjournals.org/cgi/content/...amp;keytype=ref

[sue1234]

I don't take it, but really feel for you guys. When you've found something that helps you function, it is priceless with this illness.

[Tuesday]

I have no words.

I will not be able to function without this.

I will not be able to hold a job.

Waiting to hear back from my doctor.

[Stace915]

NNNNNNNOOOOOO how is this possible? I take it every 3 hours... No, no, no!! Can we start a petition or something.... OMG... What are we supposed to do!!!!! Ahhhhh!!!

[Tuesday]

From here: http://www.medicalnewstoday.com/articles/197890.php

"The agency is working with the drug manufacturers to develop an expanded-access program to allow patients who currently receive the drug to continue to receive it. On a case-by-case basis, expanded-access programs allow the use of a drug outside of a clinical trial to treat patients with a serious or immediately life-threatening disease or a condition that has no comparable or satisfactory alternative treatment options."

Maybe there's hope?

[Noreen]

From here: http://www.medicalnewstoday.com/articles/197890.php

"The agency is working with the drug manufacturers to develop an expanded-access program to allow patients who currently receive the drug to continue to receive it. On a case-by-case basis, expanded-access programs allow the use of a drug outside of a clinical trial to treat patients with a serious or immediately life-threatening disease or a condition that has no comparable or satisfactory alternative treatment options."

Maybe there's hope?

I wonder what expaned-access program would look like and whether the insurance companies would continue to pay for a drug in that categorary.

[nmorgen]

I think stockpiling until there is a better option or you can get into the expanded access program(if it's even possible) would be a good idea. Call your doctors and let them know what is going on. My dr in the US wrote a prescription for clonidine that will last me for 2 yrs, b/c he wasn't sure if I could get it over here in Switzerland. I'm sure some of the dr will be willing to help. I would also get in contact with all of the generic makers. Maybe one of them will be willing to respond to the FDA. Maybe you should all contact the FDA and ask for details about this expanded access program. I thought it was strange that the article said to immediately stop taking the drug and then later said they would help people on a case by case basis. My heart goes out to all of you taking midodrine.

[Tuesday]

I contacted the FDA and here is the reply I got from DRUGINFO@fda.hhs.gov

"Thank you for writing to the Division of Drug Information in the FDA's Center for Drug Evaluation and Research.

FDA proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition, orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done. To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug's clinical benefit, for example, by showing that use of the drug improved a patient's ability to perform life activities. FDA today issued a Proposal to Withdraw Marketing Approval and Notice of Opportunity for a Hearing to the companies that manufacture midodrine. This is the first time the agency has issued such a notice for a drug approved under the FDA's accelerated approval regulations. Shire, the maker of the brand name drug, must respond to the FDA in writing within 15 days to request a hearing. If the company fails to do so, the opportunity for a hearing will be waived. Sponsors of generic versions of midodrine will have 30 days to submit written comments on the notice. If, after considering any relevant submissions, the FDA continues to believe that withdrawal of approval is warranted, approval of all midodrine products, including generic versions, will be withdrawn.

The agency is working with the drug manufacturers to develop an expanded-access program to allow patients who currently receive the drug to continue to receive it. On a case-by-case basis, expanded-access programs allow the use of a drug outside of a clinical trial to treat patients with a serious or immediately life-threatening disease or a condition that has no comparable or satisfactory alternative treatment options.

You may find additional information at: http://www.fda.gov/NewsEvents/Newsroom/Pre...s/ucm222580.htm

Thank you for your comments regarding this issue.

Best regards,

Drug Information RL

Division of Drug Information

Center for Drug Evaluation and Research

Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info

This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed."

[iheartcats]

The letter from Shire:

Dear Ms. X:

Thank you for your recent medical information inquiry regarding ProAmatine. We understand that you have requested information on ProAmatine discontinuation.

Shire will be discontinuing the sale of the branded drug, ProAmatine, in September 2010. Shire has made a business decision to discontinue the sale of ProAmatine. This action is not the result of any safety or efficacy issues regarding these products.

We are sorry that this action may be affecting your treatment plan. Please talk to your physician as he/she is most knowledgeable about your medical condition and can provide you with the most appropriate medical advice and guidance.

This information is supplied as a courtesy in response to your inquiry. It is not intended to recommend any indication, dosage or other claim that is not covered int he ProAmatine package insert(s).

Please discuss further questions with your physician or health care provider. He or she knows your medical history ans is in the best position to give you appropriate information about your medications.

Sincerely,

Shire Medical Information

[iheartcats]

I've seen several business and pharmacy blogs about this. This is one of the business blogs from today:

On Monday, the US Food and Drug Administration announced a proposition to pull ProAmitine (Midodrine) from the market due to Shire (SHPGY) not conducting post-approval studies to prove that the drug has a benefit.

Midodrine is currently the only FDA-approved drug for Orthostatic Hypotension. It was approved in 1996 as part of a shorter approval process under the condition that Shire conduct post-approval studies. Midodrine never was a big seller for Shire, and post-approval studies were never conducted. Midodrine was bringing in around $60M/yr as of 2005. FDA stated that around 100,000 patients filled prescriptions for brand or generic Midodrine in 2009. Take note that if the FDA withdraws the medicine's approval, generic companies including Mylan Pharmaceuticals (MYL), Impax Laboratories (IPXL), and Novartis (NVS) unit Sandoz must stop selling their generic versions of Midodrine.

The company that benefits from this decision is Chelsea Therapeutics (CHTP). Chelsea is developing Northera (droxidopa) for the treatment of Orthostatic Hypotension, with pivotal phase 3 trial results due in September.

Furthermore in Chelsea?s favor, Needham & Co analyst Alan Carr said the FDA action could help:

"The potential removal of midodrine may create a greater market opportunity for Droxidopa in the U.S.," said Carr in a research note.

If Midodrine is removed from the market, and Chelsea?s Northera study (Study 302) succeeds, the stock should most definitely be higher than it is now (if stock price rises to market potential, $6-$7 is very possible).

There is a lot of chatter and several news articles about dwindling supplies for dialysis patients and nursing homes. I don't think stockpiling is going to help.

Firewatcher - I'm borrowing your information for the Consumerist comments (about Chelsea)...I looked it up on Google and it's legitimate information! Thank you for posting. I'm not naming you or anything, just sharing the information.

http://consumerist.com/2010/08/fda-tries-t...ssure-drug.html

[vemee]

I haven't had much help from proamitine but it has definitely helped my daughter. The only other drug that I think we can fall back on is mestinon but since it is not specifically designated for orthostatic hypotension some doctors may not want to prescribe it.

[cnm1]

This would be devastating for my daughter!! I encouraged everyone to contact the FDA - even if you don't take it. I am going to check for availability in foreign countries. This is an important drug for many with dysautonomias. We need to fight this - I know I will!!!

Louise

I haven't had much help from proamitine but it has definitely helped my daughter. The only other drug that I think we can fall back on is mestinon but since it is not specifically designated for orthostatic hypotension some doctors may not want to prescribe it.