FDA’s delayed review of Nuvo’s new drug could ensure 2014 approval

The regulatory delay of Nuvo Research’s new painkiller drug in the United States could improve the drug’s chances of final approval next year, says the Mississauga-based drug developer.

In a Q & A on its website, Nuvo said Monday that the risk of the American organization not approving Pennsaid 2% has now been “significantly reduced” after being issued a complete response letter (CRL) by the U.S. Food and Drug Administration (FDA).

The CRL found two studies of the drug conducted by a contract research organization retained by Mallinckrodt, Nuvo’s U.S. licensing partner, were found “not acceptable.”

In the Q & A, Nuvo said “samples of the drug used in the studies were not retained at the clinic site,” a clear breach of FDA regulations. As a result, the FDA requires that Mallinckrodt conduct a new drug development study of Pennsaid and Pennsaid 2%. The new study would continue to test a patient’s total exposure to a drug in their blood stream.

If Mallinkrodt successfully completes the new drug study, Nuvo expects FDA approval of Pennsaid 2% for the U.S. market by the first quarter of 2014.

According to the Q & A, Mallinckrodt has hired a new research company to conduct the new drug study. However, Mallinckrodt still needs “ethical approval.” The company has advised Nuvo it expects to start the new study in about a month’s time.

Nuvo stated the delay in FDA approval would not affect the company’s revenues, due to the original Pennsaid continuing to be marketed and sold in the U.S. Nuvo also expects the generic version of Pennsaid will not enter the market until after the FDA has responded to the submitted results of the new drug study.

Pennsaid is a non-steroid anti-inflammatory drug used to treat osteoarthritis of the knees. The drug is currently supplied as a 1.5 per cent solution that can be applied on the skin.


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