Ampion was created by Dr David Bar-Or, director of research at two Colorado trauma centres, after he had noted that brain swelling after severe head injuries reduced more quickly than other swelling. His research identified naturally occurring amino acids in the blood and cerebrospinal fluid that he believed help reduce inflammation and swelling, and synthetic versions were developed to make Ampion, a non-steroidal injection and oral drug.
The substances used in Ampion are also used in Human Serum Albumin (HSA), which has been used to aid chronic dehydration for 50 years.
The clinical trials were carried out by CPR Pharma Services and involved 100 patients who reported severe knee pain from osteoarthritis. Each was given one injection of Ampion with a follow-up 30 days and then 84 days later. The trial reported no side effects for patients and positive benefits for pain relief with some patients reporting no pain at all after the injection.
Ampio Pharmaceuticals has developed Ampion and is about to begin a further round of trials involving 1,500 patients, approved by the US Food & Drug Administration (FDA). The results of the next series of trials may lead to the FDA approving Ampion for patient use within the next year, offering hope to the 8.5 million people in the UK who suffer from osteoarthritis.
Known as the “wear-and-tear” arthritis, the condition is caused by the thinning or wearing of the cartilage that surrounds the joints. It generally affects older people but also commonly develops after a joint injury, such as a fracture. In the most severe cases, patients may need joint replacement, such as a new hip or knee.