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Home | Clinical Trials

FDA Approved Drugs » 2011
Medical Areas: Gastroenterology

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Rectiv (nitroglycerin) ointment 0.4%

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

Company: ProStrakan
Approval Status: Approved June 2011
Treatment Area: chronic anal fissure

General Information

Rectiv is a nitroglycerin-based topical ointment. Nitroglycerin is converted by the body into nitric oxide, which can aid in the relaxation of the internal anal sphincter muscle and may have a role in the natural relaxation of muscles in the entire gastrointestinal tract.

Rectiv is specifically indicated for the treatment of moderate to severe pain associated with chronic anal fissure.

Rectiv is supplied as an ointment for topical administration. The recommended dose of Rectiv is 1 inch of ointment (375 mg of ointment equivalent to 1.5 mg of nitroglycerin) applied intra-anally every 12 hours for up to three weeks.

Clinical Results

FDA Approval
The FDA approval of Rectiv was based on a three week double-blind, randomized, multi-center, placebo-controlled study. Subjects with a painful chronic anal fissure for at least six weeks and moderate or severe pain prior to treatment (≥50 mm on the 100mm visual analog scale, VAS) were randomized to receive 0.4% (1.5mg) nitroglycerin or placebo ointment applied to the anal canal every 12 hours. Pain as assessed by the change in VAS from baseline to Days 14-18 was lower in subjects receiving 0.4% ointment compared to placebo. The mean change from baseline was 44mm for Rectiv and 37mm for placebo. The difference in the mean change in pain between Rectiv and placebo was -7.0mm.

Side Effects

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

  • headache
  • dizziness

Mechanism of Action

Rectiv is a nitroglycerin-based topical ointment. Nitroglycerin forms free radical nitric oxide (NO), which activates guanylate cyclase, resulting in an increase of guanosine 3’,5’-monophosphate (cyclic GMP) in smooth muscle and other tissues. This leads to dephosphorylation of myosin light chains, which regulates the contractile state in smooth muscle and results in vasodilatation. The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle. Intra-anal application of nitroglycerin reduces sphincter tone and resting intra-anal pressure.

Additional Information

For additional information regarding Rectiv or chronic anal fissures, please visit the Prostrakan web page.


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