Nuvo Research Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Mallinckrodt's New Drug Application for Pennsaid (R) (diclofenac sodium topical solution) 2% w/w (Pennsaid 2%). Pennsaid 2% is a follow-on product to original Pennsaid (diclofenac sodium topical solution) 1.5% w/w (Pennsaid 1.5%) which has been marketed by Mallinckrodt in the U.S. since 2010. Pennsaid 2% will be the first twice per day dosed topical NSAID available in the U.S. for the treatment of the pain of osteoarthritis of the knee.

Nuvo has licensed the U.S. sales and marketing rights for both Pennsaid 1.5% and Pennsaid 2% to Mallinckrodt. Pennsaid(diclofenac sodium topical solution) 2% w/w is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain of osteoarthritis of the knee(s). The most common adverse events in a phase 2 clinical trial of Pennsaid were application site reactions, such as dryness (22%), exfoliation (7%),erythema (4%), pruritus (2%), pain (2%), induration (2%), rash (2%), and scabbing (1%).

Other adverse reactions occurring in >1% of patients receiving Pennsaid included urinary tract infection (3%), contusion (2%), sinus congestion (2%), and nausea (2%). The most common treatment-related adverse events in patients receiving Pennsaid 1.5% were application site skin reactions including dry skin (32%), contact dermatitis characterized by skin erythema and induration (9%), contact dermatitis with vesicles (2%) and pruritus (4%). In a long term safety study, contact dermatitis occurred in 13% and contact dermatitis with vesicles in 10% of patients.

Other common adverse events greater than placebo include: dyspepsia (9%), abdominal pain (6%), flatulence (4%), diarrhea (4%) and nausea (4%).