Bioiberica’s combination of chondroitin sulphate and glucosamine hydrochloride, a slow action drug to treat osteoarthritis symptoms, was approved as an ethical drug in France, Austria, Hungary, Poland, and Finland through a mutual recognition process from Spain.
“This approval confirms that Drug Agencies from different countries attest to the effectiveness and safety of the combination of pharmaceutical grade chondroitin sulphate and glucosamine hydrochloride. This drug has proven to reduce pain and improve mobility in people affected by knee osteoarthritis which, due to its safety profile, could also be used as an alternative by those patients with cardiovascular or gastrointestinal problems who should not be prescribed anti-inflammatory drugs chronically” stated Dr Juan Gispert, Bioiberica’s R&D director.
The principle study that guarantees its effectiveness is the MOVES clinical trial, published in the Annals of the Rheumatic Diseases,which concludes that the combination of chondroitin sulphate and glucosamine has an effectiveness comparable to the anti-inflammatory drug celecoxib after six months of treatment in patients with osteoarthritis and moderate to severe pain.
It was observed that the combination of these two drugs relieves pain in a clinically relevant way. It also improves functional capacity, stiffness, relieves inflammation and joint effusion.
With these new approvals, a total of six European countries have approved Bioiberica brand’s combination of chondroitin sulphate and glucosamine hydrochloride. This year, the company plans to sign licensing and distribution agreements with companies specialised in the osteoarticular field to launch the product in the five countries where the drug was recently approved.
Filed Under: Drug Discovery