The US Food and Drug Administration (FDA) has approved diclofenac sodium topical solution 2% w/w (Pennsaid 2%) for knee pain caused by osteoarthritis (OA), Nuvo Research Inc announced today.
Pennsaid 2% is a follow-on product to original Pennsaid 1.5% w/w, which has been available in the United States since 2010, the company notes in a statement.
Pennsaid 2% is supplied in a metered dose pump bottle and has been approved for twice-daily dosing compared with 4 times a day for original Pennsaid 1.5%.
Pennsaid 2% will be the first twice-daily dosed topical nonsteroidal anti-inflammatory drug (NSAID) available in the United States for the treatment of knee OA pain, the company said.
Pennsaid is contraindicated in patients with a known hypersensitivity to diclofenac sodium or any other component of Pennsaid and in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.
Nuvo has licensed the US sales and marketing rights for both Pennsaid 1.5% and Pennsaid 2% to Mallinckrodt. Mallinckrodt plans to launch Pennsaid 2% in the United States in the first quarter of 2014.
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Cite this: Topical Diclofenac 2% (Pennsaid) for Knee OA Pain Clears FDA - Medscape - Jan 17, 2014.