Genitrix has launched Libromide, the first licensed formulation of potassium bromide for the treatment of canine epilepsy, following what the company believes to be the largest ever trial of dogs suffering from epilepsy.
Genitrix says the availability, for the first time, of a licensed formulation of potassium bromide should give veterinary surgeons and pet owners the reassurance that the rigorous authorisation process provides. It ensures, for instance, that the product has been developed especially for dogs and that it is manufactured in accordance with EU regulations. It also ensures that the product has been extensively and independently trialled, proven to be efficacious without adverse reactions, and that the necessary pharmacovigilance is in place to support it.
The company also says that the availability of a licensed product paves the way for more comprehensive information to be provided to veterinary surgeons on the use of potassium bromide in treating seizures. The Veterinary Medicines Directorate (VMD) imposes restrictions on educational materials supplied by manufacturers of unlicensed products, an approach which has created a 'knowledge gap' among many veterinary surgeons in general practice, according to some canine epilepsy experts.
Libromide tablets are intended for use in epileptic dogs which have already commenced therapy with Phenobarbital. Phenobarbital acts to increase the effects of the GABA inhibitory neurotransmitter in the central nervous system. Potassium bromide is synergistic with Phenobarbital and raises the seizure threshold level in epileptic dogs.
Libromide is classified as POM-V and will be available in 325 mg tablets in packs of 100 and 500 tablets.
Rodolfo Cappello DVM PhD DipECVN MRCVS, RCVS and European Specialist in Neurology and Neurosurgery, Head of Neurology Services at North Downs Specialist Referrals, Surrey, said: "I've been successfully using potassium bromide for the treatment of epilepsy in dogs for over 15 years. The main problem has been that it's not been licensed as a medicine. With the launch of Libromide, potassium bromide finally achieves the status of an approved pharmaceutical. We will now be able to monitor quality, efficacy and side effects which will enable us to offer a more professional approach to the treatment of seizures."
Howard Wilder, founder and managing director of Genitrix, added: "Canine epilepsy is an all too common disease with estimates suggesting it affects four in every hundred dogs in the UK. It's also an illness which is not well enough understood with the lack of up to date information available to veterinary surgeons being a contributing factor.
We felt there was an opportunity to bring a licensed product to market and have invested hundreds of thousands of pounds in the process of development and trialling Libromide. We're delighted to make it available to veterinary professionals and hope its launch will be the first step in improving treatment approaches for this distressing disease."
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We already use the Genetrix KBr - it will be interesting what effect POM-V status will have to its price!!!!
What! Is Epilease (VetPlus) not licensed?
@ Rob Wilson: That is my point exactly. We have been using it and looks like it is licensed for that. Am I wrong?
I think this is cherry-picking generics to make money. Look what happened to Cimetidine.
Same box, different label and huge price increase!
Here is a statement prepared by Genitrix:
Genitrix has recently launched Libromide, the first ever licensed form of potassium bromide. Until now, various unlicensed forms of potassium bromide have had to be used to control refractory epilepsy in dogs. The approval process means that Genitrix has been required to make a significant investment in the development of a formulation which complies with EU pharmaceutical regulations and has been obliged to conduct numerous studies to prove that the product is safe and efficacious.
Libromide has been launched at a higher price than the unlicensed KBr tablets formerly sold by Genitrix, reflecting the markedly increased cost of manufacture as a direct result of this necessity to comply with EU regulations. The improvement in quality which the approval process brings, gives additional peace of mind to the veterinary surgeon and pet owner alike.
It has taken Genitrix seven years to achieve this important goal, which is part of our continued commitment to provide the highest possible standard of products. The result of having a fully compliant and licensed product, is to provide reassurance and 100% confidence to pet owners, that their animals suffering from this cruel and distressing disease, experience the highest quality of life possible by receiving the highest quality of treatment possible.