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news.Roxro Pharma, a specialty pharmaceutical company, has announced that the FDA has accepted for review the new drug application for its lead investigational prescription drug candidate, ROX-888, for the management of acute moderate to severe pain.
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ROX-888 is an intranasal formulation of ketorolac, a non-steroidal anti-inflammatory drug, 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 new drug application (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 indicated for the management of acute moderate to severe pain.
Roberto Rosenkranz, CEO of Roxro, said: “We believe that ROX-888 has the potential to fill important needs in the large and growing market for acute moderate to severe pain treatments.
“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.”