NUVO RESEARCH
ANNOUNCES
FDA RESPONSE TO PENNSAID
®
2% NDA
Mississauga, Ontario,
Canada
–
March 5,2013
–
Nuvo Research Inc. (Nuvo)(TSX:NRI)
announced today that its U.S. licensing partner, Mallinckrodt
,the Pharmaceuticals Business of Covidien
(NYSE:COV),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. Pharma cokinetic 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 SAID in the US. 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.
d.
