Branded Equine Pergolide Introduced in the UK

A version of pergolide mesylate branded for equine use has been introduced in the UK by drug manufacturer Boehringer Ingelheim Limited.




Viovet, a UK veterinary medicine provider,  shows the Prascend data sheet and cost per tablet here.
What does this mean for US horses currently maintained on compounded pergolide to control their PPID symptoms?
If Viovet's cost is "typical", the equivalent cost in the US will be approximately $1.41 a day for a horse receiving one milligram of pergolide daily, or about $43.00 a month. What if your horse needs a higher dose - can you afford up to $215.00 a month, the cost of the highest dose recommended by Boehringer Ingelheim  to provide your horse with relief from the symptoms and problems associated with PPID?
Will FDA approval of an "equine" product eliminate the availability of the affordable compounded pergolide products currently used by thousands of horses? Who benefits from this - certainly not the horses or their owners.
As always, the ECIR group will continue providing up to date information, education and support for horse owners, veterinarians and other professionals involved in the care of horses with Cushing's Disease. 
See ECIRHorse.org - your reference source for Insulin Resistance and Cushing's Disease, join the Equine Cushings and Insulin Resistance support group moderated by Eleanor Kellon, VMD, and watch and like the ECIR Group - Equine Cushings and Insulin Resistance FaceBook page.

Pergolide Availability in Canada

On August 16, 2007 Health Canada issued a public communication concerning the end of Permax sales in Canada as of August 30.

As this action was anticipated, Canadian Equine Cushings Group members and Dr. Eleanor Kellon have been engaged in an ongoing proactive approach to ensure the continuation of pergolide availability for equine use has been ongoing.

The following is an excerpt from a communication received by this group from the Veterinary Drugs Directorate - Health Canada:

Secondly, the compounding of drugs is not something that we here at the Vet Drugs Directorate regulate and compounding is dealt with differently in Canada than it is in the United States. It is regulated provincially for Canadian vets and the Canadian Veterinary Medical Association also has guidelines for the use of compounded drugs in veterinary medicine. Pharmacists have their own associations which govern how their compounding practices and they can order Active Pharmaceutical Ingredients from the chemical companies that produce them even if a brand name drug is not labelled for animals. They do not need to use a brand name drug and they do not have to come through the Vet Drugs Directorate for authorization or access to the active ingredient.

As far as we know, the access that pharmacists have to the active pharmaceutical ingredient should not be affected by this recall in Canada. They should still be able to purchase the active ingredient from the chemical companies that make pergolide mesylate (that may be anywhere in the world). But only a pharmacist would be able to find out how easy or how expensive it would be for them to get the ingredient for compounding.

Updates will be provided as they become available.

Cushing's horse places second in equitation class after treatment

THIS IS WHAT EVERYONE'S HARD WORK ON THE PERGOLIDE ISSUE WAS ALL ABOUT!!

Posted to EC List May 16, 2007

My daughter's horse, Secret, started with an early case of
founder/laminitis. He was walking very stiff legged on front legs. We
called the vet. After testing, it was confirmed that he has Cushing's
disease. He is approximately 19 years old.

That was five months ago, in January. He has been on Pergolide since
then. His diet has also been changed to a very low carb diet. His
turn out is limited to about 3 hours a day.

My daughter recently took him to an "A" show locally. Together, they
placed Second in a class of about 15, age group 14 & under, in a 2'6"
equitation class.

The vet told us that after he has been on the treatment, we would
notice that it will be as if he were 5 years younger.

So far, this is true.

FDA Statement - Nuances

Posted on EC List May 15, 2007 Msg #91664

In case anyone is wondering about nuances in the FDA statement, what we
had requested was an exemption from the prohibition on compounding from
bulk drug. What we got was "regulatory discretion". The exemption would
have been a statement that they are allowing it, not considering it
illegal. The regulatory discretion basically means they'll look the
other way but technically they still consider it illegal. Either one
works for us; either one keeps the flow of drug to the compounders.
Only difference is the FDA saves face a bit more with regulatory
discretion. It's purely a matter of semantics. By either publishing an
exemption or making a public statement to the effect they will exercise
regulatory discretion in the framework of a valid prescription, they
are saying they won't move against the compounders or wholesalers. One
statement isn't any stronger than the other. Neither one actually
involves a change in law, and either one can be reversed just as
quickly as it was issued. However, until (and unless) an FDA approved
option comes along (see below), compounding will continue to be your
source of pergolide.

Also, "sponsors of approved product" refers to the 3 companies that
were making the pills before the recall; the only 3 companies that had
applied for and gotten FDA approval to market the drug. A "sponsor" is
a company that seeks FDA approval for a drug. An "approved product" is
a drug that has cleared the FDA approval process for a specific use(s).
So, the rest of the statement, beyond talking about compounding, was to
the effect that they are still trying to encourage the original pill
manufacturers to resume production, and are welcoming any new
sponsors/companies interested in picking it up specifically for equine
use.

Eleanor

Horse.com - Pergolide: FDA to Allow Compounding From Bulk

The Food and Drug Administration's (FDA) Center for Veterinary Medicine announced on May 11 it will allow bulk pergolide to be used in compounding pergolide for use in horses.

"A lot of hard work by a large number of people went into getting this resolution," Kellon [Eleanor Kellon, V.M.D.] said. "We've been working on it since the week after the announcement of the drug's withdrawal. It's been a long six weeks, but we're all pleased that the FDA acted in time to prevent any horses having to go without treatment."

Read more...

EquiSearch: FDA Clears Way for Compounding of Pergolide for Horses

A May 11 FDA announcement has cleared the way for compounding of pergolide for horses, but what does the fine print mean? Find out in this special bulletin from EQUUS magazine.

"What it boils down to is that they are allowing it for now," says Kellon [Eleanor Kellon, V.M.D.] "but if an actual drug company decides to start up manufacturing the pill form again or if a drug company wants to go down an official pathway to get it approved for equine use, the bulk compounding will again be considered illegal as soon as that source is up and running."

Read more...

It's Official - WE WON !!!

Statement just issued by FDA, Center for Veterinary Medicine

http://www.fda.gov/cvm/pergolide.htm

"CVM recognizes that veterinarians are prescribing pergolide for the treatment of Cushing’s Syndrome in horses. Veterinarians have been prescribing the drug under the provisions of the Animal Medicinal Drug Use Clarification Act which allows veterinary practitioners to prescribe approved human drugs for “extralabel” use in animals.

"FDA is working with the sponsors of the approved products and all other interested parties to ensure that pergolide remains available to treat Cushing’s Syndrome in horses until a new animal drug application is approved for that use. This includes trying to make the approved product available through veterinary distribution channels and exercising enforcement discretion as appropriate over the pharmacy compounding of pergolide. Bulk substance used for pharmacy compounding should be labeled for “animal use only.” All pharmacy compounding must be done under a valid veterinary prescription to treat an affected horse."