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Vivlodex now available in United States for osteoarthritis pain
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Iroko Pharmaceuticals LLC announced its proprietary, low-dose form of meloxicam, Vivlodex, is now available in pharmacies in the United States, according to a company press release.
In a 12-week study, Vivlodex, an NSAID, at 5-mg and 10-mg doses demonstrated efficacy in pain reduction for patients with osteoarthritis, according to the company.
“Vivlodex demonstrated significant pain relief at low 5-mg and 10-mg doses, and may present an important new treatment option for the 27 million Americans with osteoarthritis pain,” Clarence Young, MD, chief medical officer of Iroko Pharmaceuticals LLC, said in the release. “This latest launch provides patients living with osteoarthritis pain an efficacious, yet low dose, NSAID that aligns with recommendations by the FDA and leading professional organizations to use the lowest effective dose.”
The product was approved by the FDA in October 2015 and contains meloxicam in submicron particles about 10 times smaller than the original size. By reducing the size and increasing the surface area, faster dissolution and absorption may occur.
Young clarified the distinctions between Vivlodex and other meloxicam products in correspondence with Healio Rheumatology.
“Vivlodex is available in 5 mg and 10 mg capsules. In contrast, meloxicam is available as 7.5 mg and 15 mg tablets,” he wrote. “Vivlodex capsules have demonstrated efficacy in patients with osteoarthritis pain at 33% lower doses than corresponding meloxicam tablets. When administered to healthy subjects, the maximal meloxicam plasma concentration occurred at 2 hours following Vivlodex dosing compared with 4 hours following dosing with meloxicam.”
Reference: www.vivlodex.com.