26 March 2014

Fast disintegrating Indomethacin for acute pain

Indomethacin capsule with the brand name Tivorbex is a non-steroidal anti-inflammatory drug thatwas approved by USFDA inFebruary 2014 for the treatment of mild to moderate acute pain in adults.

Tivorbex was developed by IROKO Pharmaceuticals, LLC,a global specialty pharmaceutical company dedicated towardsthe advancement of the science of analgesia. Using innovative technology, Iroko has developed new drug products based on existing NSAIDs and have globally commercialized the pharmaceutical products.

Pain could be classified into two basic categories acute pain and chronic pain. Acute pain which generally lasts less than 3 to 6 months or a pain that could be directly related to soft tissue damage such as a sprained ankle or a paper cut.Acute pain would generally lastfor short duration but would gradually resolve as the injured tissues heal. Acute pain is distinct from chronic pain and is relatively more sharp and severe.

Tivorbex with active ingredient Indomethacin is available in the form of 20mg capsules for oral administration. Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. It is formulated as submicron particles that are almost 20 times smaller than their original size. The reduction in particle size provided an increased surface area which leads to faster dissolution of the drug. The faster dissolution capsules facilitate rapid drug absorption from the pre-gastric area which triggers quick onset of action of the drug. Indomethacin is administered 20mg twice daily or 20mg, 40 mg taken twice, thrice daily respectively. The lowest effective dose is used for the shortest duration depending on the individual patient treatment goals.

The FDA approval of Tivorbex was based on aphase II, multi-centric, randomized, double blinded, placebo-controlled, parallel grouped study in subjects with mild to moderate acute pain. One arm  of the study consisted of the study group subjects who were provided with Tivorbex 20mg twice daily or 20mg, 40 mg taken  thrice daily respectively (dosages depending on the individual patient treatment plans). The other arm consisted of the control group subjects, who were treated with a placebo. The study enrolled a total of 845 subjects with a minimal pain intensity rating of at least 40mm on a 100mm visual analog scale (VAS) during the 9-hour period after discontinuation of the anesthetic block.
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which could be used in questionnaires. It is used as a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. The mean pain intensity measured by VAS at baseline for all treatments groups in both studies ranged with 71 to 74mm. There was a greater use of concomitant opioid rescue medication in the placebo-treatment arm than in the Tivorbex-treatment arms which could easily signify the efficacy of the study drug compared to placebo control. Tivorbex capsules 20mg twice daily or 20mg, 40 mg taken twice, thrice respectively demonstrated a significant efficacy in pain intensity reduction compared with placebo as measured by the sum of pain intensity difference during 0 to 48hrs post the first dose.

Some of the serious adverse events reportedafter use ofTivorbexare; heart attack, stroke, high blood pressure, life-threatening skin reactions, liver problems including liver failure, cardiovascular thrombotic events, myocardial infarction,  gastrointestinal ulcers, gastro intestinal bleed and renal events such as acute renal failure.

Indomethacin was found to be effective in active stages of moderate to severe rheumatoid arthritis including acute flares to chronic disease, moderate to severe ankylosingspondylitis, moderate to severe osteoarthritis, acute painful shoulders (bursitis and tendinitis) and acute gouty arthritis.

This drug is contraindicated for pediatric patient’s under14 years of age.Itis also contraindicated to patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDS and for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Tivorbexhas been classified as a non-steroidal anti-inflammatory prescription drug (NSAID)(commonly used as a prescription medication to reduce fever, pain and swelling).It works by inhibiting the production of prostaglandins molecule known to cause these symptoms.Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain. This drug inhibits the prostaglandin secretion thus providing an analgesic effect.Tivorbex was approved at dosage strengths that are 20 percent lower than the 25 mg and 50 mg indomethacin products currently on the market.Different NSAIDS are already available in the market with analgesic and antipyretic properties but this drug would be readily available in the system and will start working at a much earlier time point compared to other market available drugs. The most significant part is the 20% reduced dose than the currently available Indomethacin drugsin the market offering an equivalent pain management which is a milestone.

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