AstraZeneca painkiller collaboration fails
pharmafile | October 27, 2003 | News story | |Â Â Â
The future of a potential new blockbuster pain killer under development by AstraZeneca is in doubt after it failed safety tests.
AZD3582, licensed from French biotech company NicOx, had been tipped as a possible rival to the COX-II inhibitors, but new phase II trial data has proven to be a disappointment. Despite showing efficacy in treating pain, the drug caused more stomach ulcers than expected, therefore undermining its benefits over existing treatments.
AstraZeneca has, however, said it remains committed to completing the ongoing phase II study of the drug, and will review all the currently available phase II data.
AZD3582 is in development for the treatment of both acute and chronic pain, and is the lead compound in NicOx's programme of COX-inhibiting nitric oxide donators (CINODs), a novel class of anti-inflammatory and analgesic drugs that have a multi-pathway mechanism of action.
COX-II inhibitors, such as Merck's Vioxx and Pfizer/Pharmacia's Celebrex, have proven to be highly successful in the treatment of arthritis, combining efficacy with claims for a superior gastrointestinal safety profile than traditional painkillers, such as ibuprofen and aspirin.
Their safety has, however, been called into question in recent months, amid claims that they may increase the risk of cardiovascular disease. The EMEA is due to publish findings of a report into the class's safety early this year.
Shares in NicOx were suspended before the announcement, with analysts predicting them to drop sharply once trading commences.
A second CINOD, AZD4717, in pre-clinical development, was chosen for development by AstraZeneca last November.
NicOx has another six nitric oxide-based compounds in clinical development for a variety of indications, including cardiovascular diseases, asthma, osteoporosis, Alzheimer's and inflammatory bowel disease.
