Roxro's intranasal ketorolac accepted for review

The US Food and Drug Administration has accepted for review the New Drug Application for Roxro's lead investigational prescription drug  candidate, ROX-888 (intranasal ketorolac), for the management of acute  moderate-to-severe pain.

The non-steroidal anti-inflammatory drug is designed to provide  ambulatory patients with a convenient, potent and fast-acting option for  acute pain relief, without the risk of addiction or the other negative  effects of narcotics. The NDA package for ROX-888 includes data from  more than 1,000 subjects and 14 clinical trials. If approved, ROX-888 is  expected to be the first non-narcotic intranasal analgesic for this  indication.

Roxro chief executive Roberto Rosenkranz said: "currently-approved forms  of ketorolac are already well accepted by the physician community for  in-hospital use, and we believe physicians will quickly adopt this  investigational intranasal form of ketorolac as a new therapeutic option  to replace or minimize oral opioid use for take-home prescriptions. As  we plan a potential product launch at the end of 2009, pending FDA  approval, we are now seeking a commercialization partner to help us  realize the full benefit of this drug."