Nuvo Research Announces US Partner Covidien Receives CRL from FDA for PENNSAID 2% NDA

Nuvo Research announced today that its U.S. licensing partner, Mallinckrodt, the Pharmaceuticals Business of Covidien

, has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) following the review of Mallinckrodt's New Drug Application (NDA) for diclofenac sodium topical solution, 2% w/w (PENNSAID 2%). In the letter, the FDA requires that Mallinckrodt successfully complete a pharmacokinetic study comparing PENNSAID 2% to original PENNSAID 1.5%. Similar pharmacokinetic studies submitted by Mallinckrodt with the NDA were not acceptable to the FDA because reserve samples were not retained at the clinical site. Pharmacokinetic studies are standard studies conducted during a drug development program to identify the total exposure or the amount of drug that reaches the blood stream after a patient receives both single and multiple doses of the product. Mallinckrodt has indicated to Nuvo that it expects to complete the study and submit the results to the FDA in the third calendar quarter of 2013, and that it anticipates the FDA will provide a formal response to the filing within 6 months thereafter. "While we are disappointed that PENNSAID 2% will not be approved in this review cycle,