Potent, Well-Tolerated Therapy Allows Simple One-Day, One-Dose Regimen
SAN ANTONIO, TX (April 20, 2006) – Mission Pharmacal today announced that it has acquired the U.S. manufacturing and commercial rights for Tindamax® (tinidazole tablets) from Presutti Laboratories, LLC.
Tindamax® is a prescription drug therapy for trichomoniasis, the most common non-viral sexually transmitted disease (STD), which is estimated to occur at a rate of about 7.4 million cases in the United States annually. The second-generation 5-nitroimidazole compound is also indicated for the treatment of intestinal infections giardiasis and intestinal amebiasis, as well as amebic liver abscess. It has been approved for use in the United States since May 2004.
"This acquisition strengthens our portfolio of prescription brands with an effective, well-tolerated and easily dosed therapy that will play a key role in the control of potentially serious conditions such as trichomoniasis, which can increase susceptibility to and transmission of HIV," said Neill Walsdorf, Jr., president of Mission Pharmacal. "Mission Pharmacal is excited about the opportunity to communicate with physicians about Tindamax® as a first-line therapy for trichomoniasis and giardiasis."
Available in 250mg and 500mg tablets, Tindamax® may be prescribed as a one-day, one-dose regimen to treat trichomoniasis, and has demonstrated high cure rates in both females and males with the STD. Sexual partners should be treated simultaneously for maximum efficacy and to prevent reinfection. In addition, Tindamax® is the only single dose therapy available for the treatment of giardiasis.
In clinical efficacy trials using a single 2g dose, Tindamax® has been shown to effectively treat trichomoniasis in 92 to 100 percent of patients. In giardiasis clinical efficacy trials, a single 2g dose of Tindamax® produced efficacy rates ranging from 80 to 100 percent. Clinical studies also show that Tindamax® provides potent in vitro activity and long duration of action, exhibiting a 12-to-14-hour half-life and therapeutic concentrations still present 48 hours following a single 2g dose.
In clinical studies, adverse events associated with the use of Tindamax® have been generally mild and self-limiting. The most common side effects have been metallic taste and nausea. In patients receiving a 2g dose, 3.7 percent experienced metallic taste and 3.2 percent experienced nausea.
About Trichomoniasis, Giardiasis, Intestinal Amebiasis, and Amebic Liver Abscess
Trichomoniasis, which is caused by the single-celled parasite Trichomonas vaginalis, 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. The STD also can contribute to reduced fertility in both men and women. It has also been linked to cervical cancer, preterm birth and postoperative infection in women. Men with trichomoniasis may suffer lower sperm motility and nongonococcal urethritis. For more information, visit www.trichomoniasis.org.
Giardiasis is an intestinal infection caused by the waterborne parasite Giardia duodenalis. According to the Centers for Disease Control and Prevention, an estimated 2.5 million cases of giardiasis occur annually in the United States.
Intestinal amebiasis is an intestinal infection caused by the protozoan parasite Entamoeba histolytica.
Amebic liver abscess, a potentially life-threatening condition, is a collection of pus in the liver caused by the intestinal parasite Entamoeba histolytica.
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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