In a European first, Pfizer Animal Health is conducting a major study in over 2000 dogs with Trocoxil, its new NSAID which delivers continuous analgesia for a month.
According to the company, Trocoxil has already been granted a licence by the EMEA and pre-authorization studies have already shown once-monthly Trocoxil to be at least as safe and effective as daily carprofen. However, the monthly dosing regimen represents such a big step from the currently used approach of daily NSAID dosing, that Pfizer has decided to initiate the study before launching the product in order to closely monitor and manage the introduction of Trocoxil to the veterinary market.
Jolian Howell, Associate Director Companion Animal Marketing for Pfizer said: "A drug with such a unique dosing regimen should be introduced in a controlled and managed way, and this study is part of that commitment by Pfizer Animal Health."
This large post-approval study, conducted under veterinary control as a User Experience Study, will enable a similar comparison with carprofen to be made in a much larger patient population. In fact it will be sufficiently large to provide product-specific safety information, such as any differences in the incidence of side-effects.
The randomised, parallel group study is being conducted in more than 100 veterinary clinics throughout France, Germany and the UK. Each dog will receive up to 6 months of treatment during which time it will be assessed every month by the veterinary surgeon.
Trocoxil, a preferential COX-2 inhibitor, has a unique pharmacological profile which means that a single oral dose provides continuous pain relief for a whole month.
Jolian added: "This study will provide veterinary surgeons with an opportunity to experience the benefits of using Trocoxil to treat OA continuously over a period of months. It will also give them the opportunity to assess the benefits this offers the owner."
PS: Whilst you're here, take a moment to see our latest job opportunities for vets.
www.emea.europa.eu/.../V-132-en6.pdf
Some useful further reading. The last page gives the main summary, for those with less time to kill.
Sorry, meant to include this one also - a useful summary of the state of play in use of cox-2 inhibitors in people
www.pubmedcentral.nih.gov/articlerender.fcgi