Oxaprozin

Template:Short description Template:Cs1 config Template:Drugbox Oxaprozin, also known as oxaprozinum, is a nonsteroidal anti-inflammatory drug (NSAID),<ref name="pmid3986088">Template:Cite journal</ref> used to relieve the inflammation, swelling, stiffness, and joint pain associated with osteoarthritis and rheumatoid arthritis. Chemically, it is a propionic acid derivative. Safety and efficacy has been established in children over 6 years with juvenile rheumatoid arthritis only, and there is an increased risk of adverse reactions in the elderly population.

It was patented in 1967 and approved for medical use in 1983.<ref name=Fis2006>Template:Cite book</ref>

Medical uses

In 2015, oxaprozin was one of twenty NSAIDs included in a clinical trial to compare the efficacy of NSAIDs in the short-term treatment of ankylosing spondylitis (AS). The NSAIDs were compared by completing randomized controlled trials of NSAIDs in patients with active AS. Efficacy reported at 2–12 weeks and adverse effects were examined. Efficacy was measured by change in pain score and change in the duration of morning stiffness. A total of 26 trials with a total of 3410 participants were completed (58% of the trials had fewer than 50 participants). While all 20 NSAIDs were found to reduce more pain than the placebo, 15 were found to be significantly better. In regards to the decrease of morning stiffness and the likelihood of adverse events, there was no significant difference between NSAIDs. It was concluded that etoricoxib was more effective in reducing pain of AS, however due to small studies and insufficient evidence, no one NSAID could be determined to be the most effective treatment of AS. After etoricoxib, patients taking oxaprozin experienced the least amount of pain with fewer adverse effects than naproxen.<ref>Template:Cite journal</ref>

Adverse effects

In October 2020, the U.S. Food and Drug Administration (FDA) required the drug label to be updated for all nonsteroidal anti-inflammatory medications to describe the risk of kidney problems in unborn babies that result in low amniotic fluid.<ref name="FDA PR 20201015" /><ref name="FDA safety 20201015" /> They recommend avoiding NSAIDs in pregnant women at 20 weeks or later in pregnancy.<ref name="FDA PR 20201015">Template:Cite press release Template:PD-notice</ref><ref name="FDA safety 20201015">{{#invoke:citation/CS1|citation |CitationClass=web }} Template:PD-notice</ref>

History

Oxaprozin was developed and patented by Wyeth-Ayerst.<ref name=":1" /> The US patent 3578671, Oxazoles, was filed November 6, 1967 and published May 11, 1971.<ref name=":2">Template:Citation</ref> Following the filing of the patent, the first description of oxaprozin exhibiting anti-inflammatory properties was outlined in the article Diaryloxazole and diaylthiazolealkanoci acids: two novel series of non-steroidal anti-inflammatory agents. This article was published in Nature in 1968.<ref>Template:Cite journal</ref><ref>Template:Cite book</ref> In December 1988, Wyeth-Ayerst licensed the marketing rights for the US, Canada, Puerto Rico, and the Caribbean to Searle.<ref name=":1" />

Daypro became available January 5, 1993. Upon its release, “The Pink Sheet” estimated that the average whole sale price of Searle's Daypro was $112.30 for 100 (600 mg) tablets.<ref name=":1" /> The price was comparable to other prescription NSAIDs.

Society and culture

FDA approval

The oxaprozin new drug application (NDA 18-841) was submitted to the FDA on August 10, 1982. The drug was granted an “NDA Day” review on June 15–16, 1992. After Searle agreed to complete seven Phase IV postmarketing studies on October 22, the FDA approved Daypro on October 29, 1992.<ref name=":1">Template:Cite book</ref>

Since the approval of Daypro by Searle, other companies have submitted abbreviated new drug applications (ANDAs) to the FDA. Daypro by Searle is listed as the Reference Listed Drug to prove the bioequivalence of the ANDAs. Below is a table listing all of the approved oxaprozin products.

citation	CitationClass=web }}</ref>	FDA Approval Date<ref name=":3" />
GD Searle	Oct 29, 1992
Apotex Inc	Sep 2, 2004
Dr. Reddy's Labs LTD	Jan 31, 2001
Ivax Sub Teva	May 13, 2002
Sandoz	Jan 31, 2002
Sun Pharm Inds Inc	Jan 3, 2002
Teva	Jul 3, 2002

Recalls

Advantage Dose LLC recalled oxaprozin tablets on November 26, 2008. The company was not in conformance with cGMP. (Recall #D-837-2009)<ref>{{#invoke:citation/CS1|citation |CitationClass=web }}</ref>