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The Food and Drug Administration has approved a low-dose formulation of meloxicam for the treatment of osteoarthritis pain, according to manufacturer, Iroko Pharmaceuticals.
The new medication, Vivlodex, is made using a proprietary technology for producing submicron-size particles of meloxicam that are 10 times smaller than their traditional size, decreasing dissolution time. In a 12-week, phase III trial of 402 osteoarthritis patients aged 40 years or older, Vivlodex in 5- and 10-mg doses achieved efficacy at 33% lower doses than with commercially available meloxicam medications. Vivlodex will be available as a once-daily medication in 5- or 10-mg doses.
The FDA and professional medical associations have recommended administering nonsteroidal anti-inflammatory drugs in as small a dose and for as short a duration as possible. Serious adverse events stemming from NSAID treatments are related to dose and risk can increase as treatment continues.
“Meloxicam is the second most commonly prescribed NSAID in the [United States]. The approval of Vivlodex is a welcome option that offers patients an effective, low-dose NSAID,” Dr. Byron Cryer, associate dean at the University of Texas Southwestern Medical Center at Dallas, said in a statement from Iroko.
The Food and Drug Administration has approved a low-dose formulation of meloxicam for the treatment of osteoarthritis pain, according to manufacturer, Iroko Pharmaceuticals.
The new medication, Vivlodex, is made using a proprietary technology for producing submicron-size particles of meloxicam that are 10 times smaller than their traditional size, decreasing dissolution time. In a 12-week, phase III trial of 402 osteoarthritis patients aged 40 years or older, Vivlodex in 5- and 10-mg doses achieved efficacy at 33% lower doses than with commercially available meloxicam medications. Vivlodex will be available as a once-daily medication in 5- or 10-mg doses.
The FDA and professional medical associations have recommended administering nonsteroidal anti-inflammatory drugs in as small a dose and for as short a duration as possible. Serious adverse events stemming from NSAID treatments are related to dose and risk can increase as treatment continues.
“Meloxicam is the second most commonly prescribed NSAID in the [United States]. The approval of Vivlodex is a welcome option that offers patients an effective, low-dose NSAID,” Dr. Byron Cryer, associate dean at the University of Texas Southwestern Medical Center at Dallas, said in a statement from Iroko.
The Food and Drug Administration has approved a low-dose formulation of meloxicam for the treatment of osteoarthritis pain, according to manufacturer, Iroko Pharmaceuticals.
The new medication, Vivlodex, is made using a proprietary technology for producing submicron-size particles of meloxicam that are 10 times smaller than their traditional size, decreasing dissolution time. In a 12-week, phase III trial of 402 osteoarthritis patients aged 40 years or older, Vivlodex in 5- and 10-mg doses achieved efficacy at 33% lower doses than with commercially available meloxicam medications. Vivlodex will be available as a once-daily medication in 5- or 10-mg doses.
The FDA and professional medical associations have recommended administering nonsteroidal anti-inflammatory drugs in as small a dose and for as short a duration as possible. Serious adverse events stemming from NSAID treatments are related to dose and risk can increase as treatment continues.
“Meloxicam is the second most commonly prescribed NSAID in the [United States]. The approval of Vivlodex is a welcome option that offers patients an effective, low-dose NSAID,” Dr. Byron Cryer, associate dean at the University of Texas Southwestern Medical Center at Dallas, said in a statement from Iroko.
