SAN ANTONIO, TX (November 13, 2006) – Mission Pharmacal announced today that its antiprotozoal drug Tindamax® (tinidazole) is now recommended as a first line therapy for the treatment of trichomoniasis in the Centers for Disease Control and Prevention's (CDC) recently issued 2006 Sexually Transmitted Diseases Treatment Guidelines. Trichomoniasis (also known as "trich") is the most common curable sexually transmitted disease (STD) in the United States, with an estimated 7.4 million cases occurring each year in women and men, compared with about 3 million new cases of chlamydia and 700,000 cases of gonorrhea. Tindamax®, which is administered orally and taken as a single 2-gram dose, has demonstrated cure rates of 92 to 100 percent.
"Inclusion in the CDC's guidelines reinforces the importance of Tindamax® in treating a very common sexually transmitted disease," said Neill Walsdorf, Jr., president of Mission Pharmacal. "Because Tindamax® has been shown to be better tolerated than metronidazole, patients and physicians alike will benefit from having this new option for first line treatment of trichomoniasis." Tindamax® as a single 2g dose is also recommended by the CDC for patients having failed treatment with single dose metronidazole.
Because trich is generally asymptomatic or only mildly symptomatic, trich-infected individuals are often in the dark about their infection. Moreover, research indicates that many healthcare professionals are under-utilizing newer point-of-care methods that more rapidly and accurately diagnose trich. Untreated, trichomoniasis can lead to both an increased risk of infertility and enhanced transmission of HIV in men and women, as well as increased risk for cervical cancer and pelvic inflammatory disease in women.
"As the most prevalent curable STD in the United States, the timely diagnosis and treatment of trichomoniasis is imperative to reducing other more serious conditions. Healthcare providers need to be vigilant about testing their patients who are sexually active for trich because they may not experience any symptoms," stated Dr. Jane Schwebke, professor of infectious diseases at the University of Alabama at Birmingham. "Fortunately, trichomoniasis can be cured with single dose therapy in both women and men."
The Sexually Transmitted Diseases Guidelines are published to assist healthcare providers in their efforts to prevent, diagnose and treat STDs. They were developed by the CDC after consultation with a group of professionals knowledgeable in the field of STDs, and serve as an update to the guidelines issued in 2002. The full report can be accessed at http://www.cdc.gov/std/treatment/default.htm.
About Trichomoniasis
Trichomoniasis, which is caused by the single-celled parasite Trichomonas vaginalis, is the most common curable sexually transmitted disease (STD) in the United States. There are an estimated 7.4 million cases of trich each year in the U.S.
Trichomoniasis is often asymptomatic or only mildly symptomatic. Signs and symptoms of trichomoniasis in women include itching, redness and a yellow, green or grey vaginal discharge that may be frothy or sticky and have a foul odor. Urination and intercourse may be painful, and the symptoms may worsen during menstruation. When symptoms are present in men, they may consist of urethral discharge and irritation.
When left untreated, trichomoniasis may enhance both the acquisition and transmission of HIV. The genital inflammation caused by trichomoniasis can increase a woman's susceptibility to HIV infection if she is exposed to the virus. Trichomoniasis also has been shown to increase the risk of infertility in women and may play a role in promoting cervical cancer and pelvic inflammatory disease. In a large Finnish study, trich was associated with a six-fold increased risk of cervical cancer in women compared with those who were uninfected. The STD has also been linked to preterm birth and postoperative infection in women, and lower sperm motility and nongonococcal urethritis in men.
Sexual partners should be treated simultaneously for maximum efficacy and prevention of re-infection. More information on trich is available at www.trichomoniasis.org.
About Tindamax®
Tindamax®, a second-generation 5-nitroimidazole compound, is indicated in the United States for the treatment of trichomoniasis, the intestinal infections giardiasis and intestinal amebiasis, and amebic liver abscess. It has been approved for use in the United States since May 2004 and is recommended as one of the drugs of choice for the treatment of trichomoniasis by the Centers for Disease Control and Prevention.
Full prescribing information for Tindamax®, as well as information about trichomoniasis, is available at www.tindamax.com.
About Mission Pharmacal
Mission Pharmacal is a family-owned pharmaceutical company based in San Antonio, Texas. For more than 60 years, the company has been dedicated to identifying unmet health needs in the marketplace and developing innovative prescription and over-the-counter products to meet them. Currently, Mission Pharmacal provides physicians and consumers with pharmaceutical, nutritional and diagnostic products. For more information, visit www.missionpharmacal.com.
Media Contact:
Ami Shah
cohn&wolfe
(212) 537-8048
ami.shah@cohnwolfe.com
Important Safety Information
WARNING: POTENTIAL RISK FOR CARCINOGENICITY
Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Its use should be reserved for the conditions described in INDICATIONS AND USAGE.
Contraindications
- Prior history of hypersensitivity to tinidazole or other nitroimidazole derivatives
- First trimester of pregnancy
- Nursing mothers, unless breast-feeding is interrupted during tinidazole therapy and for 3 days following the last dose
Warnings and Precautions
- Seizures and neuropathy have been reported. Discontinue Tindamax if abnormal neurologic signs develop
- Vaginal candidiasis may develop with Tindamax and require treatment with an antifungal agent
- Use Tindamax with caution in patients with blood dyscrasias. Tindamax may produce transient leukopenia and neutropenia
Adverse Reactions
Most common adverse reactions for a single 2 g dose of tinidazole (incidence >1%) are metallic/bitter taste, nausea, weakness/fatigue/malaise, dyspepsia/cramps/epigastric discomfort, vomiting, anorexia, headache, dizziness and constipation. To report SUSPECTED ADVERSE REACTIONS, contact Mission Pharmacal Company at 1-800-298-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
This material is intended to provide basic information. Patients should discuss all medical advice, diagnosis, and treatment with their healthcare provider.
Please see full Prescribing Information
Only Tindamax® is approved to treat both bacterial vaginosis and trichomoniasis (TV).
Clinical Insight
Oral vs vaginal cream therapy: Patient preference for oral dosing is demonstrated to be 84%. More»
Beyond BV
Tindamax® may be prescribed for other infections including:
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