DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Tivorbex (indomethacin); Iroko Pharmaceuticals; For the treatment of acute pain, Approved February of 2014
2-{1-[(4-chlorophenyl)carbonyl]-5-methoxy-2-methyl-1H-indol-3-yl}acetic acid
cas 53-86-1
PHILADELPHIA—Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved TIVORBEX™ (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults1.
“TIVORBEX is the second NSAID to be approved from Iroko’s lower dose NSAID pipeline that uses proprietary SoluMatrix Fine Particle Technology™.”
TIVORBEX was approved at dosage strengths that are 20 percent lower than the 25 mg and 50 mg indomethacin products currently on the market2. FDA approval of TIVORBEX was supported by data from two Phase 3 multi-center, placebo-controlled trials that demonstrated significant improvement in pain relief in patients with post-surgical acute pain receiving TIVORBEX compared with patients receiving placebo3.
“The FDA approval of TIVORBEX is another significant milestone for Iroko as it validates our strategic approach towards developing a suite of NSAID products that offer pain management at lower doses,” said John Vavricka, President and CEO of Iroko Pharmaceuticals. “TIVORBEX is the second NSAID to be approved from Iroko’s lower dose NSAID pipeline that uses proprietary SoluMatrix Fine Particle Technology™.” read at
Indometacin (INN) or indomethacin (USAN and former BAN) is a non-steroidal anti-inflammatory drug (NSAID) commonly used as a prescriptionmedication to reduce fever, pain, stiffness, and swelling. It works by inhibiting the production of prostaglandins, molecules known to cause these symptoms. It is marketed under more than seventy different trade names.[1]
Indomethacin was discovered in 1963[8] and it was first approved for use in the U.S. by the Food and Drug Administration in 1965. Its mechanism of action, along with several other NSAIDs that inhibit COX, was described in 1971.[9]
References
- Trade names are listed on DrugBank.ca entry DB00328
- Sanders, Lisa (6 January 2012). “Think Like a Doctor: Ice Pick Pain Solved!”. The New York Times.
- Garza, I & Schwedt, TJ. “Hemicrania continua.” UpToDate.http://www.uptodate.com/contents/hemicrania-continua. Accessed 8/27/13.
- Smyth JM, Collier PS, Darwish M et al. (September 2004). “Intravenous indometacin in preterm infants with symptomatic patent ductus arteriosus. A population pharmacokinetic study”. Br J Clin Pharmacol 58 (3): 249–58. doi:10.1111/j.1365-2125.2004.02139.x.PMC 1884560. PMID 15327584.
- “INDOMETHACIN”. Hazardous Substances Data Bank (HSDB). National Library of Medicine’s TOXNET. Retrieved April 4, 2013.
- Giles W, Bisits A (October 2007). “Preterm labour. The present and future of tocolysis”. Best Pract Res Clin Obstet Gynaecol 21 (5): 857–68. doi:10.1016/j.bpobgyn.2007.03.011.PMID 17459777.
- Akbarpour F, Afrasiabi A, Vaziri N (1985). “Severe hyperkalemia caused by indomethacin and potassium supplementation”. South Med J 78 (6): 756–7. doi:10.1097/00007611-198506000-00039. PMID 4002013.
- Hart F, Boardman P (October 1963). “Indomethacin: A New Non-steroid Anti-inflammatory Agent”. Br Med J 2 (5363): 965–70. doi:10.1136/bmj.2.5363.965. PMC 1873102.PMID 14056924.
- Ferreira S, Moncada S, Vane J (Jun 23, 1971). “Indomethacin and aspirin abolish prostaglandin release from the spleen”. Nat New Biol 231 (25): 237–9.doi:10.1038/231237a0. PMID 5284362.
- Effects of Perinatal Indomethacin Treatment on Preterm Infants, academic dissertation (PDF)
- Indomethacin, from MedicineNet
- Indomethacin, from Drugs.com
- Indocin: Description, chemistry, ingredients, from RxList.com
- Indomethacin bound to proteins in the PDB
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