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Drug - Rectiv (nitroglycerin 0.4%) [Prostrakan Inc.]

September 2012

Therapeutic Area - Topical nitrate

Approval criteria

  • Patient has a diagnosis of chronic anal fissure AND
  • Patient has tried and failed a topical calcium channel blocker AND a topical nitroglycerin product

Background information

According to the 2010 American Society of Colon and Rectal Surgeons practice parameters for the management of anal fissures, topical nitrates, topical CCBs and onabotulinumtoxinA are considered treatment options. The practice parameters state that nitrates are marginally superior to placebo. They also indicate that topical CCBs have a lower incidence of adverse events compared to nitroglycerin. A February 2012 Cochrane database review of 75 randomized control trials involving 5,031 patients with chronic fissure treated with topical glyceryl trinitrate (nitroglycerin), onabotulinumtoxinA injection or the topical CCBs found the chance of cure with use of these drugs was marginally better than with placebo. It also indicated that onabotulinumtoxinA and CCBs were equivalent to topical nitroglycerin in efficacy with fewer adverse events.


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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