Syntex Gains Approval For EC-Naprosyn

Syntex has received clearance from the US Food and Drug Administration for enteric-coated EC-Naprosyn (naproxen) delayed-release tablets. EC-Naprosyn is indicated for the treatment of pain and inflammation associated with rheumatoid arthritis and osteoarthritis.

Pharmacokinetic studies with EC-Naprosyn have revealed that it has comparable total bioavailability compared to conventional naproxen, but that it does not get taken up in the stomach. However, the new formulation does not appear to be any different to Naprosyn (same efficacy, dosing and incidence of side effects), beyond providing Syntex with another three years of marketing exclusivity for the new version. The company claims, however, that "individual patients may prefer one formulation over the other."