Oxaprozin
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| Clinical data | |
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| Trade names | Daypro |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a693002 |
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| Routes of administration |
Oral |
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| Pharmacokinetic data | |
| Bioavailability | 95% |
| Protein binding | 99% |
| Metabolism | Liver—65% oxidation and 35% glucuronic acid conjugation. 5% are active phenolic metabolites. |
| Biological half-life | 54.9 hours |
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| ChEMBL | |
| ECHA InfoCard | 100.040.254 |
| Chemical and physical data | |
| Formula | C18H15NO3 |
| Molar mass | 293.317 g/mol |
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Oxaprozin, also known as Oxaprozinum, (sold under the names: Daypro, Dayrun, Duraprox) is a non-steroidal anti-inflammatory drug (NSAID), used to relieve the inflammation, swelling, stiffness, and joint pain associated with osteoarthritis and rheumatoid arthritis. Chemically, it is a propionic acid derivative. It is available in 600 mg tablets. Normal adult dosage is 1200 mg daily, not to exceed 1800 mg per day. 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.
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.
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.
Advantage Dose LLC recalled oxaprozin tablets on November 26, 2008. The company was not in conformance with cGMP. (Recall #D-837-2009)
Clinical trials essential to the approval to DAYPRO involved 646 patients. The studies were intended to measure the effect of DAYPRO in regards to the signs and symptoms of rheumatoid arthritis in placebo and active controlled groups. The patients were given single or multiple doses equally 600 to 1800 mg/day. DAYPRO was found to be comparable to 2600 to 3900 mg/day of aspirin. Oxaprozin proved to be more effective and cause fewer adverse reactions than aspirin.
In most of the clinical trials, a 1200 mg dose was given once a day (select patients received up to 1800 mg/day). Some patients responded better to a divided dose. In order to reach its full effect, Daypro was given over the course of several days.
In order to evaluate the effectiveness of Daypro for the signs and symptoms of osteoarthritis, 616 patients participated in active controlled clinical trials against aspirin, piroxicam, and other NSAIDs. Similar to the rheumatoid arthritis clinical trials, patients were given Daypro in both variable and in fixed dosing schedules. Patients received Daypro in either single or divided doses. The variable dosing schedule ranged from 600 to 1200 mg/day and the fixed dosing schedule was set to 1200 mg/day. Oxaprozin was found to be comparable to 2600 to 3200 mg/day doses of aspirin or 20 mg/day doses of piroxicam. The once a day and divided dosing schedules were both effective. Several days of administration were needed for oxaprozin to reach its full effect.
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