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.
Tindamax® is a prescription antibiotic used to treat certain infections caused by bacteria and parasites. It is approved for treating trichomoniasis, also known as "trich," and bacterial vaginosis, or "BV" (in non-pregnant, adult women). It is also approved for treating giardiasis, also known as "giardia," amebiasis, and amebic liver abscess in patients age 3 and older.
Important Safety Information
Tindamax® is not for everyone. You should not take Tindamax® if you are in the first trimester of pregnancy. If you are nursing, Tindamax® can pass through your breast milk, so you should not take it unless you stop breastfeeding during your prescription and for 3 days after your last dose.
Tindamax® can lead to a temporary reduction in your white blood cells, so if you have been diagnosed with a blood disorder, talk to your doctor before starting a prescription.
Do not take Tindamax® if you have a history of sensitivity to tinidazole or related drugs in the nitroimidazole family. Reactions can range from mild itching, hives, or fever to Stevens-Johnson syndrome, which is a rare, life-threatening skin condition.
Certain drugs may interact with Tindamax®, so always tell your doctor about the medications you're taking before you start a prescription.
Take each dose of Tindamax® with food to lessen the risk of stomach upset and other GI side effects. Avoid any alcoholic beverages while taking Tindamax® and for 3 days afterward.
If you are undergoing hemodialysis while taking Tindamax® on the same day, consult your doctor for the appropriate dose of Tindamax®. An additional half-dose of Tindamax® at the end of dialysis may be recommended.
Antibacterial drugs, including Tindamax®, do not treat viral infections such as the common cold. When taking Tindamax® to treat a bacterial infection, it is very common to feel better early in your prescription; however, you should keep taking the medication as directed and for as long as directed by your doctor. Skipping doses or not taking all of your medication can make Tindamax® less effective. It can also allow the bacteria to build up resistance to the drug, so that it won't be treatable with Tindamax® or similar drugs in the future.
The most common side effects of Tindamax® are a metallic or bitter taste, nausea, weakness, fatigue, discomfort, indigestion, cramps, vomiting, loss of appetite, headache, dizziness, and constipation.
Some patients taking Tindamax® may also develop a yeast infection, which can require treatment with an anti-fungal drug. Talk to your doctor if you notice any unusual symptoms.
Certain patients taking Tindamax® have experienced seizures or nerve problems, with symptoms such as numbness or tingling of the hands or feet. Other side effects included vertigo, unsteady movements, insomnia, or drowsiness. Stop taking Tindamax® if you develop any abnormal symptoms.
Tinidazole, the key ingredient in Tindamax®, is related to a drug called metronidazole, which has been linked to cancer in lab rats and mice that received the drug over long periods of time. Although these effects have not been reported for tinidazole, the two drugs are chemically related and have similar effects on the body. Therefore, Tindamax® should only be used to treat infections it has been approved to treat.
To report negative side effects, contact Mission Pharmacal Company at 1-800-298-1087 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
