Zenpep

H

hmw

New member
Off the top of my head I would think delayed-release would refer to the enteric coating. Most medications that are termed as 'delayed release' have an enteric coating.

eta> I could not find any definition of 'delayed release' on the product website. However, I did find this quote in the Prescribing Information (there is a link to this from the Zenpep website.)
<div class="FTQUOTE"><begin quote>6.2 Postmarketing Experience
There is no postmarketing experience with this formulation of ZENPEP.
Delayed- and immediate-release pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase) have been used for the treatment of patients with exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, such as chronic pancreatitis. The long-term safety profile of these products has been described in the medical literature.</end quote></div> So it does seem they are referring to the enteric coating, as we know this is what the other enzyme formulations mentioned here in the quote have.
 
H

hmw

New member
Off the top of my head I would think delayed-release would refer to the enteric coating. Most medications that are termed as 'delayed release' have an enteric coating.

eta> I could not find any definition of 'delayed release' on the product website. However, I did find this quote in the Prescribing Information (there is a link to this from the Zenpep website.)
<div class="FTQUOTE"><begin quote>6.2 Postmarketing Experience
There is no postmarketing experience with this formulation of ZENPEP.
Delayed- and immediate-release pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase) have been used for the treatment of patients with exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, such as chronic pancreatitis. The long-term safety profile of these products has been described in the medical literature.</end quote></div> So it does seem they are referring to the enteric coating, as we know this is what the other enzyme formulations mentioned here in the quote have.
 
H

hmw

New member
Off the top of my head I would think delayed-release would refer to the enteric coating. Most medications that are termed as 'delayed release' have an enteric coating.

eta> I could not find any definition of 'delayed release' on the product website. However, I did find this quote in the Prescribing Information (there is a link to this from the Zenpep website.)
<div class="FTQUOTE"><begin quote>6.2 Postmarketing Experience
There is no postmarketing experience with this formulation of ZENPEP.
Delayed- and immediate-release pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase) have been used for the treatment of patients with exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, such as chronic pancreatitis. The long-term safety profile of these products has been described in the medical literature.</end quote></div> So it does seem they are referring to the enteric coating, as we know this is what the other enzyme formulations mentioned here in the quote have.
 
H

hmw

New member
Off the top of my head I would think delayed-release would refer to the enteric coating. Most medications that are termed as 'delayed release' have an enteric coating.

eta> I could not find any definition of 'delayed release' on the product website. However, I did find this quote in the Prescribing Information (there is a link to this from the Zenpep website.)
<div class="FTQUOTE"><begin quote>6.2 Postmarketing Experience
There is no postmarketing experience with this formulation of ZENPEP.
Delayed- and immediate-release pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase) have been used for the treatment of patients with exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, such as chronic pancreatitis. The long-term safety profile of these products has been described in the medical literature.</end quote> So it does seem they are referring to the enteric coating, as we know this is what the other enzyme formulations mentioned here in the quote have.
 
H

hmw

New member
Off the top of my head I would think delayed-release would refer to the enteric coating. Most medications that are termed as 'delayed release' have an enteric coating.
<br />
<br />eta> I could not find any definition of 'delayed release' on the product website. However, I did find this quote in the Prescribing Information (there is a link to this from the Zenpep website.)
<br /><div class="FTQUOTE"><begin quote>6.2 Postmarketing Experience
<br />There is no postmarketing experience with this formulation of ZENPEP.
<br />Delayed- and immediate-release pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase) have been used for the treatment of patients with exocrine pancreatic insufficiency due to cystic fibrosis and other conditions, such as chronic pancreatitis. The long-term safety profile of these products has been described in the medical literature.</end quote> So it does seem they are referring to the enteric coating, as we know this is what the other enzyme formulations mentioned here in the quote have.
 
H

hmw

New member
I doubt it, Felicia. They don't have to change the active ingredient and the pancrelipase has long been proven safe & effective. The process started years ago and the deadline (noted on the CFF website, is now 2010 so the trials have been going on and are (I assume) complete now with the final data now being compiled, etc. Some info I found...

<div class="FTQUOTE"><begin quote><b>Why did the FDA make this rule?</b>

The goal of this new rule is to make sure that pancreatic enzymes have the right amount of active ingredients to digest food; inconsistencies in enzyme formulation can cause problems with digestion. There are several types of enzymes on the market now, which vary in what they contain, how they are made and how many pills must be taken. It is difficult to know the exact amount of active ingredients in the different enzymes. By conducting clinical trials and requiring FDA approval, the manufacturing process of pancreatic enzymes will be standardized, which ensures the consistency of the capsules from batch to batch. In addition, by having more precise information on these enzymes and how effective they are, doctors will be better able to prescribe the right amount of enzymes.

<b>When will the rule take effect?</b>

The FDA's rule will take effect immediately. Enzymes that are available now will likely remain so over the next four years <i>(note: this was extended until 2010)</i> During this time, makers that choose to do so will conduct clinical trials to make sure their enzyme products are safe and effective. Once the clinical trials are complete, the FDA will look at the information and decide if that company's enzyme or enzymes should be approved. At the end of four years <i>(2010)</i>, if a maker has not received FDA approval, its enzyme product will no longer be available and your doctor will prescribe an appropriate enzyme product for you.

<b>Why haven't enzymes been approved by the FDA before?</b>

Pancreatic enzymes, like a number of older medications, were first made before the FDA required them to be tested in clinical trials to see how well they work. The FDA allowed these medications to be "grandfathered" products, so they could be put on the market without its review and approval. This new rule means that the FDA requires enzymes to meet the same standards of testing as any other new drug. Because of the importance of pancreatic enzymes for people with CF, the FDA will let these enzymes remain available in the meantime.

<b>Are clinical trials of pancreatic enzymes really necessary? Isn't this a step backward?</b>

This is a step forward in improving the quality of care for people with CF. The CF Foundation has received reports of health problems in people with CF when an enzyme product was used that did not work as it should. By requiring enzymes to be consistent in their formulation and to work properly, people with CF can be assured that they are getting the right amount of enzymes for their digestive and nutritional needs.

<b>Will I still be able to buy the enzymes that my child or I take now?</b>

The enzymes you or your child currently are taking still should be available for the next four years. <i>(2010)</i> However, the maker voluntarily can remove its enzyme products from the market before that time if they so choose. After four years <i>(2010)</i>, if the FDA approves your enzyme, it will remain available. However, if the maker decides not to apply for FDA approval or if the enzyme does not receive approval, your doctor will not be able to prescribe it and will work with you to prescribe a different enzyme.</end quote></div>
 
H

hmw

New member
I doubt it, Felicia. They don't have to change the active ingredient and the pancrelipase has long been proven safe & effective. The process started years ago and the deadline (noted on the CFF website, is now 2010 so the trials have been going on and are (I assume) complete now with the final data now being compiled, etc. Some info I found...

<div class="FTQUOTE"><begin quote><b>Why did the FDA make this rule?</b>

The goal of this new rule is to make sure that pancreatic enzymes have the right amount of active ingredients to digest food; inconsistencies in enzyme formulation can cause problems with digestion. There are several types of enzymes on the market now, which vary in what they contain, how they are made and how many pills must be taken. It is difficult to know the exact amount of active ingredients in the different enzymes. By conducting clinical trials and requiring FDA approval, the manufacturing process of pancreatic enzymes will be standardized, which ensures the consistency of the capsules from batch to batch. In addition, by having more precise information on these enzymes and how effective they are, doctors will be better able to prescribe the right amount of enzymes.

<b>When will the rule take effect?</b>

The FDA's rule will take effect immediately. Enzymes that are available now will likely remain so over the next four years <i>(note: this was extended until 2010)</i> During this time, makers that choose to do so will conduct clinical trials to make sure their enzyme products are safe and effective. Once the clinical trials are complete, the FDA will look at the information and decide if that company's enzyme or enzymes should be approved. At the end of four years <i>(2010)</i>, if a maker has not received FDA approval, its enzyme product will no longer be available and your doctor will prescribe an appropriate enzyme product for you.

<b>Why haven't enzymes been approved by the FDA before?</b>

Pancreatic enzymes, like a number of older medications, were first made before the FDA required them to be tested in clinical trials to see how well they work. The FDA allowed these medications to be "grandfathered" products, so they could be put on the market without its review and approval. This new rule means that the FDA requires enzymes to meet the same standards of testing as any other new drug. Because of the importance of pancreatic enzymes for people with CF, the FDA will let these enzymes remain available in the meantime.

<b>Are clinical trials of pancreatic enzymes really necessary? Isn't this a step backward?</b>

This is a step forward in improving the quality of care for people with CF. The CF Foundation has received reports of health problems in people with CF when an enzyme product was used that did not work as it should. By requiring enzymes to be consistent in their formulation and to work properly, people with CF can be assured that they are getting the right amount of enzymes for their digestive and nutritional needs.

<b>Will I still be able to buy the enzymes that my child or I take now?</b>

The enzymes you or your child currently are taking still should be available for the next four years. <i>(2010)</i> However, the maker voluntarily can remove its enzyme products from the market before that time if they so choose. After four years <i>(2010)</i>, if the FDA approves your enzyme, it will remain available. However, if the maker decides not to apply for FDA approval or if the enzyme does not receive approval, your doctor will not be able to prescribe it and will work with you to prescribe a different enzyme.</end quote></div>
 
H

hmw

New member
I doubt it, Felicia. They don't have to change the active ingredient and the pancrelipase has long been proven safe & effective. The process started years ago and the deadline (noted on the CFF website, is now 2010 so the trials have been going on and are (I assume) complete now with the final data now being compiled, etc. Some info I found...

<div class="FTQUOTE"><begin quote><b>Why did the FDA make this rule?</b>

The goal of this new rule is to make sure that pancreatic enzymes have the right amount of active ingredients to digest food; inconsistencies in enzyme formulation can cause problems with digestion. There are several types of enzymes on the market now, which vary in what they contain, how they are made and how many pills must be taken. It is difficult to know the exact amount of active ingredients in the different enzymes. By conducting clinical trials and requiring FDA approval, the manufacturing process of pancreatic enzymes will be standardized, which ensures the consistency of the capsules from batch to batch. In addition, by having more precise information on these enzymes and how effective they are, doctors will be better able to prescribe the right amount of enzymes.

<b>When will the rule take effect?</b>

The FDA's rule will take effect immediately. Enzymes that are available now will likely remain so over the next four years <i>(note: this was extended until 2010)</i> During this time, makers that choose to do so will conduct clinical trials to make sure their enzyme products are safe and effective. Once the clinical trials are complete, the FDA will look at the information and decide if that company's enzyme or enzymes should be approved. At the end of four years <i>(2010)</i>, if a maker has not received FDA approval, its enzyme product will no longer be available and your doctor will prescribe an appropriate enzyme product for you.

<b>Why haven't enzymes been approved by the FDA before?</b>

Pancreatic enzymes, like a number of older medications, were first made before the FDA required them to be tested in clinical trials to see how well they work. The FDA allowed these medications to be "grandfathered" products, so they could be put on the market without its review and approval. This new rule means that the FDA requires enzymes to meet the same standards of testing as any other new drug. Because of the importance of pancreatic enzymes for people with CF, the FDA will let these enzymes remain available in the meantime.

<b>Are clinical trials of pancreatic enzymes really necessary? Isn't this a step backward?</b>

This is a step forward in improving the quality of care for people with CF. The CF Foundation has received reports of health problems in people with CF when an enzyme product was used that did not work as it should. By requiring enzymes to be consistent in their formulation and to work properly, people with CF can be assured that they are getting the right amount of enzymes for their digestive and nutritional needs.

<b>Will I still be able to buy the enzymes that my child or I take now?</b>

The enzymes you or your child currently are taking still should be available for the next four years. <i>(2010)</i> However, the maker voluntarily can remove its enzyme products from the market before that time if they so choose. After four years <i>(2010)</i>, if the FDA approves your enzyme, it will remain available. However, if the maker decides not to apply for FDA approval or if the enzyme does not receive approval, your doctor will not be able to prescribe it and will work with you to prescribe a different enzyme.</end quote></div>
 
H

hmw

New member
I doubt it, Felicia. They don't have to change the active ingredient and the pancrelipase has long been proven safe & effective. The process started years ago and the deadline (noted on the CFF website, is now 2010 so the trials have been going on and are (I assume) complete now with the final data now being compiled, etc. Some info I found...

<div class="FTQUOTE"><begin quote><b>Why did the FDA make this rule?</b>

The goal of this new rule is to make sure that pancreatic enzymes have the right amount of active ingredients to digest food; inconsistencies in enzyme formulation can cause problems with digestion. There are several types of enzymes on the market now, which vary in what they contain, how they are made and how many pills must be taken. It is difficult to know the exact amount of active ingredients in the different enzymes. By conducting clinical trials and requiring FDA approval, the manufacturing process of pancreatic enzymes will be standardized, which ensures the consistency of the capsules from batch to batch. In addition, by having more precise information on these enzymes and how effective they are, doctors will be better able to prescribe the right amount of enzymes.

<b>When will the rule take effect?</b>

The FDA's rule will take effect immediately. Enzymes that are available now will likely remain so over the next four years <i>(note: this was extended until 2010)</i> During this time, makers that choose to do so will conduct clinical trials to make sure their enzyme products are safe and effective. Once the clinical trials are complete, the FDA will look at the information and decide if that company's enzyme or enzymes should be approved. At the end of four years <i>(2010)</i>, if a maker has not received FDA approval, its enzyme product will no longer be available and your doctor will prescribe an appropriate enzyme product for you.

<b>Why haven't enzymes been approved by the FDA before?</b>

Pancreatic enzymes, like a number of older medications, were first made before the FDA required them to be tested in clinical trials to see how well they work. The FDA allowed these medications to be "grandfathered" products, so they could be put on the market without its review and approval. This new rule means that the FDA requires enzymes to meet the same standards of testing as any other new drug. Because of the importance of pancreatic enzymes for people with CF, the FDA will let these enzymes remain available in the meantime.

<b>Are clinical trials of pancreatic enzymes really necessary? Isn't this a step backward?</b>

This is a step forward in improving the quality of care for people with CF. The CF Foundation has received reports of health problems in people with CF when an enzyme product was used that did not work as it should. By requiring enzymes to be consistent in their formulation and to work properly, people with CF can be assured that they are getting the right amount of enzymes for their digestive and nutritional needs.

<b>Will I still be able to buy the enzymes that my child or I take now?</b>

The enzymes you or your child currently are taking still should be available for the next four years. <i>(2010)</i> However, the maker voluntarily can remove its enzyme products from the market before that time if they so choose. After four years <i>(2010)</i>, if the FDA approves your enzyme, it will remain available. However, if the maker decides not to apply for FDA approval or if the enzyme does not receive approval, your doctor will not be able to prescribe it and will work with you to prescribe a different enzyme.</end quote>
 
H

hmw

New member
I doubt it, Felicia. They don't have to change the active ingredient and the pancrelipase has long been proven safe & effective. The process started years ago and the deadline (noted on the CFF website, is now 2010 so the trials have been going on and are (I assume) complete now with the final data now being compiled, etc. Some info I found...
<br />
<br /><div class="FTQUOTE"><begin quote><b>Why did the FDA make this rule?</b>
<br />
<br />The goal of this new rule is to make sure that pancreatic enzymes have the right amount of active ingredients to digest food; inconsistencies in enzyme formulation can cause problems with digestion. There are several types of enzymes on the market now, which vary in what they contain, how they are made and how many pills must be taken. It is difficult to know the exact amount of active ingredients in the different enzymes. By conducting clinical trials and requiring FDA approval, the manufacturing process of pancreatic enzymes will be standardized, which ensures the consistency of the capsules from batch to batch. In addition, by having more precise information on these enzymes and how effective they are, doctors will be better able to prescribe the right amount of enzymes.
<br />
<br /><b>When will the rule take effect?</b>
<br />
<br />The FDA's rule will take effect immediately. Enzymes that are available now will likely remain so over the next four years <i>(note: this was extended until 2010)</i> During this time, makers that choose to do so will conduct clinical trials to make sure their enzyme products are safe and effective. Once the clinical trials are complete, the FDA will look at the information and decide if that company's enzyme or enzymes should be approved. At the end of four years <i>(2010)</i>, if a maker has not received FDA approval, its enzyme product will no longer be available and your doctor will prescribe an appropriate enzyme product for you.
<br />
<br /><b>Why haven't enzymes been approved by the FDA before?</b>
<br />
<br />Pancreatic enzymes, like a number of older medications, were first made before the FDA required them to be tested in clinical trials to see how well they work. The FDA allowed these medications to be "grandfathered" products, so they could be put on the market without its review and approval. This new rule means that the FDA requires enzymes to meet the same standards of testing as any other new drug. Because of the importance of pancreatic enzymes for people with CF, the FDA will let these enzymes remain available in the meantime.
<br />
<br /><b>Are clinical trials of pancreatic enzymes really necessary? Isn't this a step backward?</b>
<br />
<br />This is a step forward in improving the quality of care for people with CF. The CF Foundation has received reports of health problems in people with CF when an enzyme product was used that did not work as it should. By requiring enzymes to be consistent in their formulation and to work properly, people with CF can be assured that they are getting the right amount of enzymes for their digestive and nutritional needs.
<br />
<br /><b>Will I still be able to buy the enzymes that my child or I take now?</b>
<br />
<br />The enzymes you or your child currently are taking still should be available for the next four years. <i>(2010)</i> However, the maker voluntarily can remove its enzyme products from the market before that time if they so choose. After four years <i>(2010)</i>, if the FDA approves your enzyme, it will remain available. However, if the maker decides not to apply for FDA approval or if the enzyme does not receive approval, your doctor will not be able to prescribe it and will work with you to prescribe a different enzyme.</end quote>
 
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