Nuvo Pennsaid Mid-2006 Filing Planned Following Positive Phase III Results

The trial of the topical osteoarthritis therapy was designed to address questions raised in FDA’s August 2002 “not approvable” letter, Nuvo says.

Nuvo expects to file an amended NDA for its topical osteoarthritis therapy Pennsaid in mid-2006, following the release of positive Phase III results, the company said Jan. 16.

The Phase III trial (study 112) "was designed with the advice and recommendations provided by [FDA] to address specific deficiencies in the FDA non-approvable letter received by Nuvo in August 2002," the Markham, Canada-based company (formerly Dimethaid) said.

The 12-week trial in 775 patients with symptoms of primary arthritis of the knee compared five topical and oral treatment regimens: Pennsaid (1.5% w/w diclofenac sodium solution) plus oral placebo, topical placebo (containing a small amount of DMSO for blinding purposes) plus oral placebo, topical vehicle-control (containing the same concentration of DMSO as in Pennsaid) plus oral placebo, topical placebo plus oral diclofenac and Pennsaid plus oral diclofenac.

The Pennsaid/placebo arm was statistically superior to the placebo/placebo in all three primary efficacy endpoints: pain relief, improvement in physical function and patient overall health assessment, Nuvo reported.

The company said it included the Pennsaid/oral diclofenac arm to address an FDA question about the safety profile of Pennsaid when used in combination with an oral non-steroidal anti-inflammatory drug.

"The combination showed no increased incidence of the usual side effects, just the expected additive profiles of Pennsaid alone plus oral diclofenac alone," Nuvo said.

Nuvo anticipates releasing long-term safety data from the open-label follow-up trial (study 112E) in mid-February. The follow-up is designed to address safety deficiencies listed in FDA's not approvable letter and will be included in the amended NDA, the company said.

-Andrew Kasper