Novartis said on Monday it has won U.S regulatory approval for its Voltaren Gel, the first topical prescription treatment for pain associated with osteoarthritis.
The US approval was based on several studies, including the results of two randomized, double blind, placebo-controlled efficacy studies and a twelve month safety study.
The efficacy and safety of Voltaren Gel were studied in clinical trials involving more than 900 patients with knee or hand osteoarthritis.
According to the Swiss pharmaceuticals company, the trials demonstrated Voltaren Gel to be highly effective in treating osteoarthritis, a chronic condition characterized by the breakdown of cartilage in the joint.
The gel can be applied directly to site of the osteoarthritis pain.
It also offers a favourable safety profile compared to oral drugs due to minimal drug absorption, Novartis said.
October 22 2007
Related Links
Novartis
Bookmark with:
- Digg
- Reddit
- Del.icio.us
- Facebook
- Newsvine
Sign Up to Exec UK now for FREE!