Nuvo Research Inc. 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, we are pleased that the FDA has outlined a clear pathway to approval that we believe can be completed in a relatively short time frame," said Dr. Bradley Galer, President of Nuvo's Pain Group. "Upon approval, PENNSAID 2% will be the first and only topical NSAID in the U.S. featuring twice per day dosing and a metered dose pump bottle." PENNSAID 2% is a follow-on product to original PENNSAID which is currently marketed in the U.S. by Mallinckrodt under license from Nuvo. PENNSAID 2% is a topical nonsteroidal anti-inflammatory drug (NSAID) containing 2% diclofenac sodium compared to 1.5% for original PENNSAID. It is more viscous than original PENNSAID, is supplied in a metered dose pump bottle and was studied in clinical trials using twice daily dosing compared to four times a day for original PENNSAID.