Pennsaid(R) Phase 3 study results to be published in leading international PAIN journal
PAIN is the world’s leading publication on pain research and treatments and the official journal of the International Association for the Study of Pain (IASP(R)). The IASP, founded in 1973, is the leading professional forum for science, practice, and education in the field of pain and has more than 6,500 members in 118 countries who are professionals involved in the research, diagnosis and treatment of pain.
The scientific article details Nuvo’s previously announced study results, which demonstrated that Pennsaid is efficacious for the relief of symptoms in patients with knee osteoarthritis. In addition, the study demonstrated that Pennsaid is as effective as oral diclofenac at relieving knee osteoarthritis symptoms but with less NSAID-related systemic toxicity. The article, titled, “Efficacy and safety of topical diclofenac containing dimethyl sulfoxide (DMSO) compared with those of topical placebo, DMSO vehicle and oral diclofenac for knee osteoarthritis”, was written by Dr.
“The publication of this article in the premier international pain journal further confirms Pennsaid’s unique and compelling efficacy and safety profile among all other topical NSAIDs,” said Dr.
Nuvo resubmitted its application for Pennsaid approval to the FDA in
The subject of the PAIN article is Nuvo’s Phase 3 trial, Study 112, which enrolled 775 patients in the U.S. and
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 request to review the side effect profile of Pennsaid if combined with an oral NSAID. This combination showed no increased incidence of the usual systemic side effects, just the expected additive profiles of Pennsaid alone plus oral diclofenac alone.
Dry skin was the most common adverse event with Pennsaid use. Fewer digestive system adverse events and laboratory abnormalities (decreased hemoglobin and increased AST, ALT and creatinine) were observed with Pennsaid as compared to oral diclofenac.
About Nuvo Research Inc.
Nuvo is focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies. Nuvo’s lead product is Pennsaid(R), a topical non-steroidal anti-inflammatory drug (NSAID) used for the treatment of osteoarthritis. Nuvo intends to leverage its skin-penetrating technologies to create a portfolio of topical and transdermal products targeting a variety of indications.
Nuvo Research Inc. is a publicly traded, Canadian pharmaceutical company headquartered in
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SOURCE Nuvo Research Inc.