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Pennsaid(R) Phase 3 study results to be published in leading international PAIN journal
Date:4/23/2009

's Pain Group. "This published data provides further support to our conclusion that Pennsaid, when approved by the U.S. Food and Drug Administration (FDA), will be the best-in-class product available in the United States."

Nuvo resubmitted its application for Pennsaid approval to the FDA in February 2009. The FDA has indicated that it intends to advise Nuvo of its decision regarding the approval of Pennsaid by August 5, 2009 (the "PDUFA Date") under the Prescription Drug User Fee Act.

The subject of the PAIN article is Nuvo's Phase 3 trial, Study 112, which enrolled 775 patients in the U.S. and Canada with symptoms of primary osteoarthritis of the knee. Patients in this five-arm, double-blind, 12-week trial applied a topical solution and took an oral pill. The five arms were: 1) Pennsaid plus oral placebo, 2) topical placebo containing a small amount of DMSO for blinding purposes (DMSO facilitates delivery of diclofenac to the knee) plus oral placebo, 3) topical vehicle-control (containing the same concentration of DMSO as in Pennsaid) plus oral placebo, 4) topical placebo plus oral diclofenac and 5) Pennsaid plus oral diclofenac.

Pennsaid (arm 1) was superior to placebo (arm 2) with statistically significant improvement in all three primary clinical endpoints required by the FDA: pain relief (p=0.019), improvement in physical function (p=0.046) and improved patient overall health assessment (POHA) (p(less than)0.0001).

Additional results from the trial show that Pennsaid (arm 1) was superior to vehicle control (arm 3) (pain, p=0.009; physical function, p=0.026; POHA, p=0.016). There was no difference between vehicle control (arm 3) and placebo (arm 2) indicating that DMSO alone is ineffective against the symptoms of knee osteoarthritis (p greater than 0.05). There was no difference between Pennsaid (arm 1) and oral diclofenac (arm 4) for all three efficacy endpoints (p greater than 0.05). Arm 5 was included in the trial at the FDA's
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SOURCE Nuvo Research Inc.
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