PARIS - The FDA has approved the investigational new drug application submitted by NicOx S.A. in support of Phase I clinical trials of its nitric oxide-releasing aspirin derivative, NCX 4016, in the treatment of pain and inflammation.

Preliminary human clinical studies in the UK demonstrated the safety and overall tolerability of NCX 4016, which had already been shown in animal models to have excellent gastric tolerability. Preclinical tests also indicated NCX 4016 had more potent analgesic activity than ordinary aspirin, as well as significant protective activity against acute myocardial infarct, unlike aspirin.

NicOx now plans to carry out further Phase I trials of the drug both in the U.S. and elsewhere. According to the company's CEO, Michele Garufi, it also plans to develop NCX 4016 in other indications, with "prevention and treatment of cardiovascular disorders being our next target."

Based in Sophia Antipolis, in southern France, the company is developing a range of nitric oxide-releasing compounds for pathologies such as osteoporosis, osteoarthritis, thrombosis, urinary incontinence, inflammatory bowel disease, asthma and Alzheimer's disease. In December it began Phase IIa trials of its lead compound, a nitro-flurbiprofen derivative for the treatment of Paget's disease (a form of osteoporosis), at hospitals in England and Scotland. The same compound is also being developed for the treatment of urinary incontinence and in dermatology. (See BioWorld International, Dec. 29, 1999, p. 6.)