Meloxicam is a
widely-used nonsteroidal anti-inflammatory drug (NSAID) used for
and in 2006 the generic version became available.
The approval of meloxicam was the result of a “cluster” review approach, one of the process improvements FDA has instituted to facilitate the review of generic drug applications. FDA’s Office of Generic Drugs (OGD) has begun to review groups of applications submitted at the end of 5 year new chemical entity exclusivity in “clusters” to increase efficiency and decrease review time. At the expiration of 5 year exclusivity, FDA often receives multiple applications from different sponsors, submitted on the same day. In the case of meloxicam, OGD received over 20 abbreviated new drug applications and FDA’s review team effort resulted in the approval of 13 generic applications for this product in a little over 9 months of review time, resulting in the first time any generic version of this product is available. Because all of the patents have expired for Mobic, approval of meloxicam is likely to represent immediate savings to the American public. In 2005, according to the online magazine, Drug Topics, meloxicam was ranked 38th in dollar sales of brand-name drugs in the United States, with sales totaling close to a billion dollars.
Cochrane Database Syst Rev. 2009.Single dose oral meloxicam for acute postoperative pain in adults. In the absence of evidence of efficacy, at present, for oral meloxicam in acute postoperative pain, its use in this indication is not justified. Because trials clearly demonstrating analgesic efficacy in the most basic of acute pain studies is lacking, use in other indications should be evaluated carefully. Given the large number of available drugs of this and similar classes, there is no urgent research agenda.
Curr Med Res Opin.
2015. Efficacy and safety of low-dose SoluMatrix meloxicam in the treatment of
osteoarthritis pain: a 12-week, phase 3 study. Nonsteroidal anti-inflammatory
drugs (NSAIDs) such as meloxicam are commonly used to treat osteoarthritis (OA)
but are associated with potentially serious dose-related adverse events (AEs).
SoluMatrix meloxicam has been developed with the goal of enabling effective
treatment at low doses. This phase 3 study evaluated the efficacy and safety of
low-dose SoluMatrix meloxicam capsules 5 mg and 10 mg administered once daily
for 12 weeks in patients with OA-related pain. Low-dose SoluMatrix meloxicam may
have a potential role as a new therapeutic option for the management of