Nuflexxa approved for treatment of pain in osteoarthritis of the knee
EAST BRUNSWICK, N.J., December 7, 2004 -- Savient Pharmaceuticals announced that it had received approval from the FDA for its premarket approval application (PMA) for Nuflexxa (1% sodium hyaluronate). Nuflexxa is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen). The product is also approved in Europe where it will be marketed under the brand name Euflexxa.
Nuflexxa is the first and only non-avian derived HA approved in the U.S.
Savient is in the process of completing a supplement to the labeling to support room temperature storage versus the refrigerated expiration dating approved by the FDA. The supplement is expected to be submitted early in the first quarter of 2005.
The CDC and the Arthritis Foundation report that the number of Americans with arthritis or chronic joint symptoms in 2002 was estimated at 70 million (1 in 3 adults), twice the prevalence of 1985. According to a study recently published by Millennium Research Group, in 2004 the U.S. market for hyaluronic acid (HA) treatments of osteoarthritis is approximately $350 million, an increase of 11% from 2003.
Source: Savient Pharmaceuticals
Posted: December 2004