Nuvo sees Pennsaid phase 3 trial results in January, forms panel to guide FDA application

New York, Dec. 15 - Nuvo Research Inc. said it expects preliminary results from its pivotal phase 3 trial of Pennsaid in January and has formed an advisory panel to guide its submission to the Food and Drug Administration for approval.

An amended New Drug Application is anticipated in the middle of next year.

Pennsaid is a topical non-steroidal anti-inflammatory for the treatment of osteoarthritis and is already approved for sale in Canada and several European countries.

"Our advisory panel has extensive experience with FDA submissions and will prove invaluable as we prepare for this event," said Henrich Guntermann, Nuvo's president and chief executive officer, in a news release. "If approved by the FDA, we believe Pennsaid will be the first topical NSAID to market in the U.S."

Nuvo also said talks are continuing with licensing partners for the United States. The company is also discussing its "next generation" product, Pennsaid Plus.

The phase 3 trial of Pennsaid includes at least 750 patients with osteoarthritis of the knee and is randomized, multi-site, double blinded and controlled. Nuvo is also carrying out a long-term safety study with 360 patients who have been treated with Pennsaid for six months. About 145 of those will have continued with Pennsaid treatment for a further six months.

Nuvo is a Markham, Ont., pharmaceutical company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.