Mallinckrodt, the US licensing partner of Nuvo Research Inc. for Pennsaid (diclofenac sodium topical solution) 1.5% w/w and Pennsaid 2% (diclofenac sodium topical solution) 2% w/w has submitted the results of a pharmacokinetic (PK) study to the US Food and Drug Administration (FDA) in support of its New Drug Application for Pennsaid 2%.
On March 4, 2013, Mallinckrodt received a Complete Response Letter (CRL) from the FDA following the review of Mallinckrodt’s New Drug Application for Pennsaid 2%. In the CRL, the FDA required that Mallinckrodt complete a PK study comparing Pennsaid 2% to original Pennsaid. Mallinckrodt completed the PK study and on August 7, 2013 submitted the clinical study report to the FDA. The FDA is expected to advise Mallinckrodt if the resubmission is acceptable for review within 14 days of the filing and to provide a formal response to Mallinckrodt within six months of the filing.
Pennsaid is a non-steroidal anti-inflammatory drug (NSAID) used for treating the signs and symptoms of osteoarthritis of the knee(s). Pennsaid is the only FDA-approved topical NSAID for the treatment of knee osteoarthritis which demonstrated statistically significant differences in all three primary efficacy endpoints: pain and physical function (WOMAC), patient overall health assessment (POHA), and patient global assessment of knee osteoarthritis.
Pennsaid is a registered trademark of Nuvo Research Inc.
WOMAC is a registered trademark of Nicholas Bellamy.
Pennsaid 2% is a follow-on product to original Pennsaid which is currently marketed in the US by Mallinckrodt under license from Nuvo. Pennsaid 2% is a topical non-steroidal 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.
Nuvo is a specialty pharmaceutical company, building a portfolio of products for the treatment of pain through internal research and development.