B.GOA.2402 - Colere Consultancy: goat pain relief phase 2
The goat industry along with MLA, AHA, GICA and Troy Animal Healthcare have been exploring the opportunity to register an oral non-steroidal anti-inflammatory drug, meloxicam (Butec), for use in goats.
| Project start date: | 13 September 2024 |
| Project end date: | 30 June 2025 |
| Publication date: | 13 August 2025 |
| Project status: | Completed |
| Livestock species: | Goat |
| Relevant regions: | Western Australia, Victoria, Cold wet, South Australia, Dry, Queensland, Mediterranean, Tropical warm season wet, Sub-tropical moist, Tasmania, Sub-tropical sub-humid, Temperate, Temperate sub-humid, Tropical Moist, Tropical wet |
|
Download Report
(0.5 MB)
|
|
Summary
This is the second phase in the Goat Pain Relief work program. The first phase delivered a recommended path through the regulatory process for the Butec (buccal meloxicam) product in goats, and provided the first assessment of the likely studies required. The report provided analysis of the likely risks (matched with mitigatory options) and identified ways to reduce the cost and complexity of the modules required by APVMA for registration. Funding has now been secured from the Commonwealth government to support (at least in part) the development of the regulatory package, opening up the need to manage the work program. This consultancy project is designed to maintain industry impetus in the current collaboration and bridge the gap through to the initiation of the R&D investment that will deliver the required studies.
Objectives
This project will expand on the work already completed to investigate the opportunity to register meloxicam, by consulting with the APVMA to get clear instruction on what steps need to be taken to achieve this.
Key findings
The past six months have provided significant clarification as to the complexity, cost and methodology for developing a comprehensive regulatory package that would successfully allow Australian goat producers to have access to an 'over the counter' pain relief product for their animals. Major breakthroughs include:
• improved potential position in relation to the number and scope of studies required for a registration
• while not yet confirmed, efficacy may be a lower risk/issue than previously envisaged – all levels of pain relief is a positive outcome and pain is ubiquitous (regardless of cause), meaning there may be scope for a more extensive label
• the need to approach the pre-application assistance consultation (PAA) with data from an animal study and all previous relevant information – correlating relevant information will assist in achieving the best possible outcome and a reduced trial burden.
Benefits to industry
While access to pain relief products is a high priority for the industry, there is a clear understanding that the path and process to gain this access through APVMA registration of a pain product is complex and costs difficult to define. The project was designed to seek clarity in process and cost, before further commitment is made by industry. It is likely that this project will be one of the largest ever undertaken by this industry, and all effort needs to be made to maximise leverage and reduce unnecessary expenditure.
MLA action
MLA will continue to support research in this area to work towards registering an oral non-steroidal anti-inflammatory drug, Meloxicam (Butec) for use in goats.
Future research
At the conclusion of the project, the next steps were identified by the consultant:
1. Provide a response to APVMA's NSAID Draft Guideline
2. Progress preliminary studies
3. New pre-application assistance consultation (PAA)
4. Negotiate commercial partnership.
More information
| Project manager: | Michael Laurence |
| Contact email: | Reports@mla.com.au |
| Primary researcher: | Colere Group Pty Ltd |
