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Friday, March 16, 2012

Cushing's Disease: Pergolide Compounding Update as FDA Issues Statement on Use of Pergolide Products for Animals


 This statement may also be read on the FDA web site. This statement was posted on March 16, 2012.

On September 7, 2011, the U.S. Food and Drug Administration (FDA or Agency) approved a new animal drug application (NADA) for a product containing pergolide mesylate (NADA 141-331) marketed under the trade name Prascend Tablets for the control of the clinical signs associated with Cushing’s Disease in horses. Consistent with this approval, the Agency is announcing that it intends to consider the factors set forth in Compliance Policy Guide (CPG) Sec. 608.400 - Compounding of Drugs for Use in Animals (CPG 7125.40) in evaluating potential enforcement actions involving the compounding of pergolide products for animal use from bulk active pharmaceutical ingredient (API).

In the past, veterinarians prescribed human pergolide products to treat Cushing’s Disease in horses under the “extralabel” use provisions of the Federal Food, Drug, and Cosmetic Act. However, in May 2007, the human pergolide products were removed from the market due to concerns about cardiac side effects in humans. At that time FDA stated that it would work with the sponsors of approved human products and others to ensure that pergolide remained available to treat Cushing’s Syndrome in horses until a new animal drug application was approved for that use. FDA stated that this would include, among other things, exercising enforcement discretion as appropriate over the pharmacy compounding of pergolide for use in animals.

Consistent with our previous statement, based on the approval of Prascend, FDA intends to apply the Federal Food, Drug, and Cosmetic Act requirements regarding new animal drugs to animal drugs containing pergolide that are compounded from bulk API in accordance with CPG 608.400.

The preceding text is the message published today by the FDA.

In Monday's Federal Register, the change becomes official and the verbiage is a little more clear. It includes this summary statement:

SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides for the veterinary prescription use of pergolide mesylate tablets in horses for the control of clinical signs associated with Pituitary Pars Intermedia Dysfunction (Equine Cushing’s Disease).

Download the full Federal Register documentation in PDF format.

Photo of pony with Cushings disease at top courtesy of University of Nottingham School of Veterinary Medicine and Science.

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Lerrin said...

Moderator- please pull comment if duplicate- had login problems! ha!

Good to see pergolide will still be available- but questions arise:

1) Will Boehringer Ingelheim Vetmedica be the sole vendor for this product? If so- it's a monopoly, and I fear price-gouging.

2) What will prevent this drug from falling into orphan drug status (if the financials for this product aren't to the benefit of Boehringer Ingelheim Vetmedica?)

3) Does this mean that we can no longer have pergolide prescriptions be prepared by the trusted compounding pharmacy of our choice?

Fran Jurga said...

Hi Lerrin, thanks so much for your comment and for your valid concerns about the availability of pergolide in the future for horses with ECD. Please check back; I have an update to this story that is in the works and should be posted soon!

Jane W said...

Just found this marvellous blog, thank you.
Our 28-year old QH just diagnosed and on the Prascend; we too have concerns about the price. However, our major concern is the fact that the vet said there have been concerns about the stability and efficacy of the compounded preparations.
One report is saw said the preparation was stable only for 30 days!!!
Interested in hearing what others know about this. A friend has a TB on the compounded preparation.