Canada's Nuvo says that the FDA wants to see more data on Pennsaid before it will fully approve the osteoarthritis therapy, but added that the agency doesn't expect a new late-stage trial. Its stock dropped 13 percent on the news as analysts speculated that the FDA may be looking for additional data on elderly patients with a certain skin disorder. One analyst estimated that the agency's request could delay a launch by eight to 12 months. Pennsaid would be the first topical NSAID drug to hit the multi-billion dollar osteoarthritis pain market.
"The matters raised in the approvable letter do not relate to clinical efficacy or clinical safety of Pennsaid as evidenced in Nuvo's phase 3 trials and the FDA has not requested that Nuvo conduct any additional Phase III clinical trials," Nuvo said in a statement. "In order to resolve certain matters raised in the approvable letter, the company may be required to generate additional data before approval."
- see the press release from Nuvo
- here's the report on Nuvo from The Globe & Mail
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