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Home » Drug Information » FDA Approved Drugs » 2014
Medical Areas: Neurology | Family Medicine

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Tivorbex (indomethacin)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Iroko Pharmaceuticals
Approval Status: Approved February of 2014
Treatment Area: acute pain

General Information

Tivorbex (indomethacin) is a submicron particle, low dose formulation of indomethacin, a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic and analgesic properties.

Tivorbex is specifically indicated for treatment of mild to moderate acute pain in adults.

Tivorbex is supplied as a capsule for oral administration. The recommended dose is 20 mg orally three times daily or 40 mg orally two or three times daily. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Clinical Results

FDA Approval
The FDA approval of Tivorbex was based on two multicenter, randomized, double-blind, placebo-controlled, parallel arm studies comparing Tivorbex 20 mg three times daily, 40 mg twice daily, 40 mg three times daily, and placebo in patients with pain following bunionectomy (Study 1 and Study 2). The two studies enrolled a total of 835 subjects with a minimal pain intensity rating of at least 40 mm on a 100-mm visual analog scale (VAS) during the 9-hour period after discontinuation of the anesthetic block following bunionectomy surgery. The mean pain intensity measured by VAS at baseline for all treatment groups in both studies ranged from 71 to 74 mm. One tablet of hydrocodone/acetaminophen 10 mg/325 mg was permitted every 4 to 6 hours as rescue medication. There was a greater use of concomitant opioid rescue medication in the placebo-treated arm than in the Tivorbex-treated arms. In Study 1, 89% of subjects in the Tivorbex 20 mg three times daily group, 90% of the subjectsin the Tivorbex4 40 mg twice daily group, 82% in the Tivorbex 40 mg three times daily group, and 97% of subjects in the placebo group took rescue medication for pain management during the study. In Study 2, 87% of subjects in the Tivorbex 20 mg three times daily group, 76% of the subjects in the Tivorbex 40 mg twice daily group, 80% in the Tivorbex 40 mg three times daily group, and 89% of subjects in the placebo group took rescue medication for pain management during the study. In both studies, Tivorbex Capsules 20 mg three times daily, 40 mg twice daily and 40 mg three times daily, demonstrated efficacy in pain intensity reduction compared with placebo, as measured by the sum of pain intensity difference over 0 to 48 hours after the first dose.

Side Effects

Adverse events associated with the use of Tivorbex may include, but are not limited to, the following:

  • nausea
  • post procedural edema
  • headache
  • dizziness
  • vomiting
  • post procedural hemorrhage
  • constipation
  • pruritus
  • diarrhea
  • dyspepsia
  • post procedural swelling
  • presyncope
  • rash
  • abdominal pain (upper)
  • somnolence
  • pruritus generalized
  • hyperhidrosis
  • decreased appetite
  • hot flush
  • syncope

Mechanism of Action

Tivorbex (indomethacin) is a submicron particle, low dose formulation of indomethacin, a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic and analgesic properties. The mechanism of action of Tivorbex like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Additional Information

For additional information regarding Tivorbex or acute pain, please visit the Iroko web page.