Covidien and Nuvo Research win FDA approval for osteoarthritis drug

Mon. November 09, 2009; Posted: 12:59 AM

Nov 09, 2009 (Datamonitor via COMTEX) -- NRIFF | Quote | Chart | News | PowerRating -- Covidien, a US-based provider of healthcare products, and Nuvo Research, a Canadian drug development company, have received the FDA's approval of its new drug application for Pennsaid topical solution 1.5% w/w.

According to Covidien, Pennsaid topical solution is a non-steroidal anti-inflammatory drug (NSAID) used for the treatment of the signs and symptoms of osteoarthritis of the knee.

In June 2009, the companies announced that Mallinckrodt, a Covidien company, has entered into a licensing and development agreement with Nuvo that encompasses Pennsaid topical solution and its follow-on topical diclofenac formulation, Pennsaid Plus gel, which is currently under development.

Under the agreement, Covidien is responsible for all US commercialization activities, including marketing, selling and medical education and is responsible for the clinical development of Pennsaid Plus. Nuvo owns and maintains the intellectual property rights to the products and will also be responsible for manufacturing.

The launch of Pennsaid topical solution, which Covidien anticipates in the first half of calendar 2010, will include a NSAID medication guide for prescribers, pharmacists and patients.

Timothy Wright, president of pharmaceuticals at Covidien, said: "Building on more than a century of pain treatment experience, Covidien is focused on expanding the limits of pain therapy by combining proven drugs with innovative delivery systems. We are pleased to be collaborating with Nuvo Research on this opportunity to expand our branded pharmaceutical portfolio by selling and marketing Pennsaid throughout the US."

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