Ruituoxi®

Product:	Ruituoxi (Nitroglycerin Ointment, 0.2%)
Indication:	Treatment for acute and chronic anal fissures
Status:	Phase III

PUMC Pharmaceutical’s nitroglycerin ointment is a first-line treatment for severe pain associated with acute and chronic anal fissures.

Diagnosing Acute and Chronic Anal Fissures

Anal fissures are ischemic ulcers in the squamous epithelium of the anus; acute fissures will heal spontaneously over the course of several weeks, while chronic fissures will fail to heal.

The severe pain associated with both acute and chronic fissures is due mostly to hypertonicity of the anal canal, which causes spasming of the internal anal sphincter, impairing blood flow to the anal mucosa.

Surgical vs Chemical Treatments

The goal of any treatment regimen is to relieve hypertonicity and thereby increase blood flow to the affected area. In the case of unhealable chronic fissures, a sphincterectomy, involving a surgical incision of the internal anal sphincter, may be required to reduce the amount of resting pressure on the sphincter, and thereby enable healing of the fissure.

Although surgery can effectively heal chronic anal fissures, common side effects include reduction of anal sphincter tone, fecal incontinence, and other bowel disorders.

Alternatively, so-called "chemical" sphincterectomies involving topical muscle relaxants to reduce spasming and increase blood flow represent a minimally invasive, more cost-effective option to surgery.

PUMC Pharmaceutical's nitroglycerin ointment

Results from Phase III clinical trials demonstrate that PUMC Pharmaceutical’s 0.2% nitroglycerin ointment, when applied three times daily to the anal canal, relaxes anal muscle spasm and increases blood flow, thereby relieving pain and promoting healing of the fissure.

PUMC Pharmaceutical’s 0.2% nitroglycerin ointment is an exclusively licensed, proprietary reformulation of ProStrakan’s Rectogesic®, which is currently marketed in the EU. In the United Kingdom, commercialization of Rectogesic® has reduced the number of annual sphincterectomy cases by approximately 50%.