On June 25, 2012, the FDA indexed deslorelin acetate (brand name Suprelorin F) for use in pet ferrets suffering from adrenal gland disease. Deslorelin has been discussed for years as a treatment for adrenal gland disease (adrenal cortical disease) in pet ferrets, but it’s been difficult to obtain in the United States, because it’s not an approved drug by the FDA and it’s manufactured in Australia. U.S. veterinarians who wanted to use the deslorelin implant to treat adrenal gland disease had to follow a complicated procedure that included paperwork and contacting specific distributors. Now that it is indexed, veterinarians only need to write a prescription to obtain it.
Frank Hurtig, DVM, MBA, is director of technical services for Virbac Corporation in the United States. He said that Virbac hopes to have supplies of Suprelorin F available by prescription in the United States sometime in the third quarter of 2012. Until that time, veterinarians who wish to obtain it must follow the current process for ordering (contacting Peptech Virbac and following FDA importation). He mentioned that veterinarians who wish to be notified by Virbac later this year when Suprelorin F is available should contact Virbac to provide their email. Contact information for Virbac is available on its website.
The process to get deslorelin indexed wasn’t easy. Following the normal course of a New Animal Drug Application (NADA) requires extensive and expensive studies, Hurtig said. That might be a roadblock for companies to develop drugs for species with a more limited market like ferrets or for uncommon ailments in major species. The Minor Use And Minor Species Animal Health Act of 2004 sought to eliminate this roadblock, and deslorelin is now one drug to benefit from the MUMS act. Hurtig said that Suprelorin F was developed by Peptech Animal Health of Australia, and Peptech began the process to have the FDA recognize it. In May 2011, Virbac acquired Peptech and continued this process.
Deslorelin underwent study and an expert panel of veterinarians including Robert A. Wagner, VMD, Diplomate ABVP-ECM, Karen L. Rosenthal, DVM, MS, and Mark R. Finkler, DVM, unanimously found that the benefits of using Suprelorin F implants outweigh the risks in ferrets suffering from adrenal gland disease. The FDA reviewed the expert panel’s findings and made its decision.
Hurtig said that being indexed is not the same as being approved. The labeling guidelines are very strict, indicating that Suprelorin F should only be used in ferrets, and it is for the management of adrenal gland cortical disease. Only veterinarians can order it and only veterinarians should administer it.
“We think the response by vets, clients and patients will be very good,” Hurtig said. “We’re really pleased to have had an opportunity to work with the FDA and achieve indexing.”
And what about the future for Suprelorin F? Will the process for FDA approval continue? “We’ll see how the product goes in the United States and evaluate it on an annual basis,” Hurtig said. “It may be that it’s worth pursuing a full NADA for this product in the future.”
Katie Carr, a ferret owner from Kansas, is excited about the news. “I hope this means that the implant will now be readily available to all ferret owners since virtually all, or at least most, ferrets will get adrenal disease,” she said. Carr also hopes this means veterinarians who might have held back on deslorelin will keep it in stock and recommend it as a treatment and a preventive.
Sukie Crandall, a ferret owner from New Jersey, is also happy about the news. “Having had two ferrets who could not have adrenal surgery and whose lives were extended with true quality-of-life thanks to Suprelorin implants, we are happy for ourselves that this medication will become more readily available,” she said. She added that her joy at this change doesn’t end there. “In the decade when I was a moderator of the Ferret Health List, I encountered far too many who were not prepared for the high costs of surgery or of Lupron depots [to treat adrenal gland disease].”
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