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New Drug Application seeks U.S. approval for tinidazole second-generation STD therapy

ARLINGTON HEIGHTS, ILL., Nov. 3, 2003-- Presutti Laboratories announced that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for tinidazole, a second-generation therapy for the treatment of trichomoniasis, giardiasis, intestinal amebiasis and amebic liver abscess. The advanced compound has both anti-anaerobic and anti-protozoal properties.

"This medication is well established with over 25 years of proven efficacy and safety outside the United States as an important treatment option for widespread and potentially serious conditions," said John Presutti, president of Presutti Laboratories. "We are pleased to develop tinidazole for use in this country because it may offer significant advantages over currently available therapy."

Tinidazole is a second-generation 5-nitroimidazole compound that has been found in studies to provide greater potency, an improved side-effect profile with one half the nausea and vomiting, and a longer duration of action compared to metronidazole, a first-generation 5-nitroimidazole.

Tinidazole is currently available on a compassionate use basis from Presutti Laboratories for the treatment of metronidazole-resistant trichomoniasis and metronidazole-resistant giardiasis, and was recently granted orphan drug status by the FDA for the treatment of giardiasis.

Trichomoniasis is the most common of the treatable sexually transmitted diseases, and new cases have been estimated to affect 5 million women alone in the United States each year. This includes many cases that have been reported resistant to metronidazole, currently the only approved treatment for this disease in the United States. Published clinical studies have also demonstrated that oral metronidazole is associated with high levels of gastrointestinal upset, nausea, dyspepsia and unpleasant taste.

Caused by the single-celled trichomonad parasite, a growing range of research has found that trichomoniasis can contribute to reduced fertility in both men and women, and may enhance both the acquisition and transmission of HIV. It has also been linked to cervical cancer, preterm birth and postoperative infection. Men with trichomoniasis may suffer lower sperm motility and nongonococcal urethritis.

Signs of trichomoniasis in women can include a yellow, gray or green frothy vaginal discharge -- in many cases with a foul odor -- and burning, itching, soreness and redness of the vulva or vagina are often present. Urination and intercourse may be painful, and the signs and symptoms may worsen during menstruation.

Trichomoniasis is frequently asymptomatic in men, who may often unknowingly transmit the infection to their sexual partners. When symptoms are present in men, they may consist of urethral discharge and irritation.

Giardiasis is the most common intestinal parasite in the United States and was recently listed by the U.S. Centers for Disease Control and Prevention as a nationally notifiable infectious disease. Caused by the waterborne parasite Giardia intestinalis, symptoms of the disorder may include diarrhea, abdominal pain, flatulence, bloating, vomiting and weight loss.

Diagnosis of giardiasis is usually made by examining stool samples for the presence of ova and parasites. Newer antigen tests are more sensitive and will detect more cases. Chronic cases can lead to dehydration and even death, while long-term consequences in children can include malnutrition and impairment of physical and cognitive development.

Amebiasis is caused by the parasite Entamoeba histolytica and is estimated to be the second leading cause of mortality from parasitic disease on a worldwide basis. Typically transmitted via contaminated water or food, symptoms of intestinal amebiasis may include loose stools, stomach pain and cramping. In more severe cases, patients may experience severe stomach pain, weight loss, bloody stools and fever, and intestinal lesions and ulcers may appear. Amebic liver abscesses may also occur, which can lead to death.

In clinical studies, treatment with a single 2-g dose of tinidazole has been found effective in more than 96 percent of patients with trichomoniasis, and in a study of 24 patients with metronidazole-resistant trichomoniasis, 92 percent were cured after high-dose tinidazole therapy. Despite the high doses, none of the patients discontinued tinidazole treatment due to side effects.

For giardiasis, a single 2-g dose of tinidazole has been shown to have efficacy of approximately 90 percent after four weeks. In contrast, metronidazole must be dosed for several days (5-7) to treat giardiasis effectively. For amebiasis, 2 g of tinidazole once per day for three days was shown to achieve efficacy of more than 92 percent. This is also a shorter dosing regimen than that required for metronidazole.

Source: Presutti Laboratories

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Posted: November 2003


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