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news.Canadian company Nuvo Research has said that the FDA has requested more data relating to the osteoarthritis drug Pennsaid slowing down the approval of the treatment.
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Pennsaid is a topical non-steroidal anti-inflammatory drug (NSAID) used for the treatment of osteoarthritis and is currently approved for sale in Canada and several European countries.
In a recent meeting with the FDA, the additional requirements for approval as outlined in the approvable letter were discussed.
Nuvo said the matters raised in the approvable letter do not relate to efficacy or safety of Pennsaid as evidenced in Nuvo’s phase III trials and the FDA has not requested that Nuvo conduct any additional phase III clinical trials.
“We are obviously disappointed that approval of Pennsaid may be delayed,” said Henrich Guntermann, president and CEO. “We will continue to work with our advisors and the FDA to determine the appropriate path forward to secure the approval of Pennsaid in the US”
Nuvo continues to be in discussions with potential partners for the licensing of Pennsaid in the US.