Current products in the market do not prevent chronic pain but are palliative, relieving symptoms temporarily. Multimodal pharmacological injection strategies combine opioids with non-steroidal anti-inflammatory drugs (NSAIDs) and other drugs to prevent the transition from acute to chronic pain. However, they require high doses which leads to significant side effects, toxicity and low efficacy.
A biocompatible carrier for localised drug delivery
Undertaken with the support of the Marie Skłodowska-Curie Actions programme, the TherGelFas project developed an injectable product to improve current interventions that inhibit nerves during and after surgery. “Our goal was to combine advanced materials to generate a product that can release NSAIDs and other drugs in a controlled manner and thus prevent acute pain from becoming chronic,” explains project coordinator and CEO of i+Med, Manu Muñoz. The TherGelFas solution consists of a nanostructured hydrogel based on hyaluronic acid and has the capacity to immobilise and release different drugs. The polymer is biocompatible and biodegradable, and has antiseptic properties. Its main advantage is that it releases the drugs at the target site in a controlled manner. This extends the therapeutic effect and lowers the drug concentration achieved with conventional methods. It also improves the pharmacokinetic profile of drugs which translates to lower toxicity and fewer side effects. “Our approach essentially offers existing drugs the opportunity to perform more effectively at lower doses,” notes Muñoz. Researchers synthesised new formulations of hydrogels and tested their capacity to carry and release active drugs. Hydrogel nanoparticles suitably functionalised were additionally tested for better drug control. The different TherGelFas hydrogel formulations underwent physicochemical testing to ensure correct viscosity, suitable mechanical properties, stability and biodegradability. Safety screening in vitro and in vivo has generated encouraging results for evaluating the product further for efficacy in clinical studies.
Towards improved pain management
It is widely accepted that to prevent chronic pain, it is paramount to initiate anti-pain medication early on during or after surgery. “By combining several technologies and advanced biomaterials, we obtained an industrially scalable medicinal product, ready to be tested and certified for effective pain management,” adds Muñoz. Importantly, the TherGelFas injectable polymer can be employed in ‘fast track’ recovery methodologies where a combination of commonly used medications is applied. The correct spatiotemporal release of drugs on nerves overcomes random spreading and ensures greater efficacy. The researchers are currently in the process of producing the injectable hydrogel under good manufacturing practice (GMP) conditions, ready to be tested in the clinic following regulatory approval. A business plan analysis and a feasibility study have already been performed for commercialisation and marketing of the product. Considering that chronic pain conditions pose a significant socio-economic burden and may lead to disability retirement, the TherGelFas drug administration strategy has the potential to reduce treatment and healthcare costs. Most importantly, it can contribute to the prevention of chronic pain, improving the quality of life of afflicted individuals.
TherGelFas, drug, chronic pain, hydrogel, NSAID, injectable polymer