Roxro Pharma Inc. announced Friday that the U.S. Food and Drug Administration has accepted to review a new drug application for its anti-inflammatory nasal spray.
The Menlo Park's company's lead candidate, ROX-888, is designed to provide patients in the emergency room, leaving the ER or post surgery with fast-acting relief — taking effect in about 20 minutes —without the risk of addiction or other negative effects of narcotics.
The company said it has successfully completed 14 clinical trials, involving more than 1,000 patients.
CEO Roberto Rosenkranz said Roxro has advanced the drug from early clinical development through to the FDA review in roughly seven years with less than $50 million in financing, and only a few employees.
The product may be ready for launch at the end of 2009, Rosenkranz said, pending FDA approval.
Roxro closed its second round of funding in June 2007 with $42.7 million. The round was led by Prospect Venture Partners and Sutter Hill Ventures, both of Palo Alto. Rosenkranz said that funding should last them through this year, but it is already seeking potential commercialization partners to bring the drug to market.
“We could commercialize it ourselves,” Rosenkranz said. “But it makes more sense to partner than to go that way.”