Pharmacia suffers delay in USA for injectable COX-2 inhibitor parecoxib

The US Food and Drug Administration has asked for more informationbefore it can complete its review of Pharmacia's injectable COX-2 inhibitor parecoxib sodium, a new drug intended to complement its blockbuster Celebrex (celecoxib).

The FDA sent Pharmacia a not-approvable letter for parecoxib, citing deficiencies in the dossier filed in support of its proposed indication, the treatment of moderate-to-severe pain such as that seen in patients undergoing surgery. Pharmacia downplayed the significance of the delay, saying that it should be able to supply the required data to the agency within the next 12-to-18 months. The firm said it would be meeting with FDA officials shortly to pin down what will be required to advance the application. The deficiencies in the dossier are not thought to relate to the safety or efficacy of the drug, but rather to the size - and statistical power - of the studies submitted in support of the application.

As an injectable analgesic and the leading drug in the new injectable COX-2 class, parecoxib would be expected to address a market currently dominated by opioid drugs, including morphine. While falling short of the multibillion sales potential of the oral COX-2 inhibitors, an injectable version could still target a market worth several hundred million dollars a year. Scott Key, an analyst at Banc of America Securities, told Reuters that he had forecast sales of parecoxib in 2002 of around $150 million.