Trichomonas Infections

Multiplex Vaginal Panel (MVP) delivers faster identification of three distinct conditions within an hour SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This multiplex vaginal panel can now be performed in near-patient settings, enabling results within 60 minutes from a single specimen for Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV). This expanded claim exemplifies Cepheid's commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care. The test runs on Cepheid's GeneXpert Xpress instruments and has been approved for testing women fourteen years of age and older. Cepheid's Xpert® Xpress MVP: Designed to Uncomplicate the Diagnosis of Vaginitis Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP

LIKMEZ™ (metronidazole) Oral Suspension, the First and Only FDA-Approved Liquid Option for Patients with Adherence Hurdles such as Dysphagia, Difficulty Swallowing Kesin Pharma Launches Novel Formulation of Mainstay Anti-Infective, Metronidazole Kesin Pharma: Solutions for Better Health™ OLDSMAR, Fla.--(BUSINESS WIRE)-- Kesin Pharma Corporation, a pharmaceutical company focused on innovative Specialty brands and Unit Dose formulations, announced today that the U.S. Food and Drug Administration (FDA) has approved LIKMEZ™ (metronidazole) oral suspension, 500 mg/5 mL. Available now, LIKMEZ™ is the first and only FDA-approved ready-to-use oral liquid metronidazole in the U.S. market. LIKMEZ™ is a novel presentation of a mainstay antibiotic drug, reinvented to address common adherence issues. Kesin is the exclusive U.S. commercialization partner for LIKMEZ™ through its collaboration with Saptalis Pharmaceuticals, LLC, the developer and NDA holder of the product. LIKMEZ™ is a novel proprietary liquid formulation of metronidazole for patients who may struggle with dysphagia, difficulty swallowing, or high taste sensitivities. These potential compliance and persistency obstacles can lead to treatment discontinuation and inefficient treatment outcomes, including rebound infection. LIKMEZ™ is approved for the treatment of trichomoniasis and anaerobic bacterial infections in adults and amebiasis in adults and pediatric patients. LIKMEZ™ comes in a 200 mL bottle as a strawberry peppermint flavored suspension, with a 24-month shelf life and does not require refrigeration. Metronidazole has been shown to be carcinogenic in mice and rats, and the most common adverse reactions to metronidazole include nausea, headache, anorexia, vomiting, diarrhea, abdominal cramping, epigastric distress, and constipation. LIKMEZ™ addresses inherent risks associated with crushing tablets for those patients needing a liquid formulation and eliminates the potential inconsistences associated with extemporaneously compounding metronidazole prescriptions. Additionally, compounding can amplify the pronounced bitter, metallic taste of metronidazole tablets, which can also negatively influence patients’ adherence to therapy. “LIKMEZ™ is for patients and providers who need a liquid option for those faced with adherence obstacles due to taste sensitivities or difficulty swallowing. An increasing number of patients can benefit from a safe and efficacious product that can support medication adherence. We are very excited with our first brand launch which is part of our upcoming pipeline of novel products, designed to address unmet patient needs and bring value to the healthcare system,” said Narasimhan Mani, President & CEO of Kesin Pharma Corporation. “We are pleased with our partnership with Saptalis Pharmaceuticals, the NDA holder and manufacturer of LIKMEZ™. The timely approval of this NDA505(b)(2) presents a significant opportunity for Kesin Pharma to bring a value-added product to the market,” said Narasimhan Mani. LIKMEZ™ will be available through most full-line wholesalers and retail pharmacies. To learn more and view Full Prescribing Information, including complete BOXED WARNING and additional Safety Information see . About Kesin Pharma Kesin Pharma Corporation, based in Oldsmar, FL, is a specialty pharmaceutical company with deep experience and strong capabilities in commercial sales & marketing, distribution, and market access. Kesin’s mission is to provide unique healthcare solutions to patients through our portfolio of strategic, value-driven brand and unit-dose products. Kesin Pharma works closely with patients, payers, and provider partners to bring to market innovative pharmaceutical products to better address unfulfilled needs and enhance patient adherence and accessibility. For more information, visit . About Saptalis Pharmaceuticals, LLC Saptalis Pharmaceuticals, LLC is a rapidly growing pharmaceutical company specialized in development, manufacturing, and commercialization of generic and innovative products in liquid and semi-solid dosage forms. Located in the Hauppauge Industrial Park on Long Island, NY, USA, Saptalis has fully equipped Research & Development Laboratories and state of the art commercial scale manufacturing facility designed to meet FDA cGMP requirements. For more information, visit . Important Safety Information INDICATIONS AND USAGE LIKMEZ™ (metronidazole) is a nitroimidazole antimicrobial indicated for: Trichomoniasis in adults Amebiasis in adults and pediatric patients Anaerobic Bacterial Infections in adults To reduce the development of drug-resistant bacteria and maintain the effectiveness of LIKMEZ™ and other antibacterial drugs, LIKMEZ™ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. WARNING: POTENTIAL FOR CARCINOGENICITY Metronidazole has been shown to be carcinogenic in mice and rats. Avoid unnecessary use of LIKMEZ™. Reserve LIKMEZ™ for use in the following indications: trichomoniasis, amebiasis, and anaerobic bacterial infections. See full prescribing information for complete BOXED WARNING. CONTRAINDICATIONS Hypersensitivity Reactions: LIKMEZ is contraindicated in patients with known hypersensitivity to metronidazole or other nitroimidazole derivatives. Psychotic Reactions with Disulfiram: LIKMEZ is contraindicated in patients who have used disulfiram within the last two weeks. Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. Interaction with Alcohol: LIKMEZ is contraindicated in patients who consume alcohol or products containing propylene glycol during and for at least three days after LIKMEZ therapy. Use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing. Cockayne Syndrome: LIKMEZ is contraindicated in patients with Cockayne syndrome. WARNINGS AND PRECAUTIONS Potential for Carcinogenicity: Metronidazole has been shown to be carcinogenic in mice and rats. Reserve LIKMEZ for use in the following indications: trichomoniasis, amebiasis, and anaerobic bacterial infections. Central and Peripheral Nervous System Effects: Encephalopathy, aseptic meningitis, peripheral neuropathy (including optic neuropathy) and convulsive seizures have been reported with metronidazole. The appearance of abnormal neurological signs and symptoms demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy. Fungal Superinfections: Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with LIKMEZ and requires treatment with an antifungal agent. Blood Dyscrasias: LIKMEZ is a nitroimidazole and should be used with care in patients with evidence of or history of blood dyscrasia. Total and differential leukocyte counts are recommended before and after therapy. Drug-Resistant Bacteria: Prescribing LIKMEZ in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Adverse Reactions The most serious adverse reactions in patients treated with metronidazole have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. Persistent peripheral neuropathy has been reported in some patients receiving prolonged administration of metronidazole. In addition, headache, syncope, dizziness, vertigo, incoordination, ataxia, confusion, dysarthria, irritability, depression, weakness, and insomnia have been reported. The most common adverse reactions reported: Gastrointestinal: The most common adverse reactions reported have been referable to the gastrointestinal tract, particularly nausea, sometimes accompanied by headache, anorexia, and occasionally vomiting; diarrhea; epigastric distress; and abdominal cramping and constipation. Mouth: A sharp, unpleasant metallic taste is not unusual. Furry tongue, glossitis, and stomatitis have occurred; these may be associated with a sudden overgrowth of Candida which may occur during therapy. Dermatologic: Erythematous rash and pruritus. Hematopoietic: Reversible neutropenia (leukopenia); reversible thrombocytopenia. Cardiovascular: QT prolongation has been reported, particularly when metronidazole was administered with drugs with the potential for prolonging the QT interval. Flattening of the T‑wave may be seen in electrocardiographic tracings. Hypersensitivity: Urticaria, erythematous rash, Stevens-Johnson Syndrome, toxic epidermal necrolysis, flushing, nasal congestion, dryness of the mouth (or vagina or vulva), and fever. Renal: Dysuria, cystitis, polyuria, incontinence, and a sense of pelvic pressure. Instances of darkened urine have been reported by approximately one patient in 100,000. Although the pigment which is probably responsible for this phenomenon has not been positively identified, it is almost certainly a metabolite of metronidazole and seems to have no clinical significance. Other: Proliferation of Candida in the vagina, dyspareunia, decrease of libido, proctitis, and fleeting joint pains sometimes resembling “serum sickness”. Cases of pancreatitis, which generally abated on withdrawal of the drug, have been reported. Patients with Crohn’s disease are known to have an increased incidence of gastrointestinal and certain extraintestinal cancers. There have been some reports in the medical literature of breast and colon cancer in Crohn’s disease patients who have been treated with metronidazole at high doses for extended periods of time. A cause-and-effect relationship has not been established. Crohn’s disease is not an approved indication for LIKMEZ. DRUG INTERACTIONS Disulfiram: Psychotic reactions have been reported in alcoholic patients who are using metronidazole and disulfiram concurrently. LIKMEZ is contraindicated in patients who have taken disulfiram within the last two weeks. Alcoholic Beverages: LIKMEZ is contraindicated in patients who consume alcohol or products containing propylene glycol during and for at least 3 days after therapy with LIKMEZ. Use of LIKMEZ with alcohol or other products containing propylene glycol is associated with a disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, and flushing) Warfarin and other Oral Anticoagulants: Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. When LIKMEZ is prescribed for patients on this type of anticoagulant therapy, prothrombin time and INR should be carefully monitored. Lithium: In patients stabilized on relatively high doses of lithium, short-term use of LIKMEZ has been associated with elevation of serum lithium concentrations and signs of lithium toxicity due to the interaction between metronidazole and lithium. Monitor serum lithium and serum creatinine concentrations for several days after beginning treatment with LIKMEZ to detect any increase that may precede clinical symptoms of lithium toxicity. Busulfan: Metronidazole has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity. Do not administer LIKMEZ concomitantly with busulfan unless the benefit outweighs the risk. Inhibitors of CYP450 Liver Enzymes: The simultaneous administration of LIKMEZ and drugs that decrease microsomal liver enzymes, such as cimetidine, may prolong the half-life and decrease plasma clearance of metronidazole. Inducers of CYP450 Liver Enzymes: The simultaneous administration of LIKMEZ and drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma concentrations of metronidazole. Impaired clearance of phenytoin has also been reported. Drugs that Prolong the QT Interval: QT prolongation has been reported. Drug/Laboratory Test Interactions: Metronidazole may interfere with certain types of determinations of serum chemistry values. Values of zero may be observed. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary: Most studies did not show an increased risk for congenital anomalies or other adverse fetal outcomes following metronidazole exposure during pregnancy. Lactation Risk Summary: There are no data on the effects of metronidazole on milk production. Pediatric Use: The safety and effectiveness of LIKMEZ for the treatment of amebiasis have been established in pediatric patients. The safety and effectiveness of LIKMEZ for the treatment of trichomoniasis and anaerobic bacterial infections have not been established in pediatric patients. Geriatric Use: In elderly geriatric patients, monitoring for LIKMEZ associated adverse events is recommended. Decreased liver function in geriatric patients can result in increased concentrations of metronidazole that may necessitate adjustment of metronidazole dosage. Renal Impairment: Patients with end-stage renal disease may excrete metronidazole and metabolites slowly in the urine, resulting in significant accumulation of metronidazole metabolites. Monitoring for LIKMEZ associated adverse events is recommended. Hepatic Impairment: Patients with hepatic impairment metabolize metronidazole slowly, with resultant accumulation of metronidazole in the plasma. For patients with severe hepatic impairment, reduce the dose of LIKMEZ by 50%. For patients with mild to moderate hepatic impairment, no dosage adjustment is needed but these patients should be monitored for LIKMEZ associated adverse reactions. OVERDOSAGE There is no specific antidote for metronidazole overdose; therefore, management of the patient should consist of symptomatic and supportive therapy. In case of an overdose, patients should contact a physician, poison control center, or emergency room. Please see full Prescribing Information, including BOXED WARNING at LIKMEZ™ and the stylized LIKMEZ™ logo are registered trademarks of Saptalis Pharmaceuticals, LLC. LIKMEZ™ is marketed by Kesin Pharma Corporation. © 2023 Kesin Pharma Corporation. All rights reserved.

In 2021, Evvy launched the first and only at-home vaginal microbiome test to use metagenomic sequencing. Evvy, a female-founded startup focused on vaginal health, picked up $14 million to scale up its precision health platform for women. The health tech company launched its vaginal health test in 2021 before expanding its platform in February of this year to offer end-to-end care. Patients are connected through the platform to virtual health coaches so they may better understand the results of physician-reviewed vaginal health tests and personalized prescription treatment.  Along with the fresh capital, Evvy will be launching the addition of sexually transmitted infections (STIs) and antibiotic resistance testing as an add-on panel to its vaginal health test. Priyanka Jain, CEO and co-founder of Evvy, told Fierce Healthcare that many patients came to the startup asking for STI care. Through the new addition, antibiotics being prescribed to treat STIs will be tailored to account for vaginal microbiome health.  “If you have a healthy, protected microbiome, what that’s doing is making it difficult for STIs or other pathogenic bacteria to survive,” Jain said. “The environment is too acidic, there’s no room for them. So by maintaining a healthy microbiome, research has shown that you’re reducing the chances of getting an STI in the first place. They’re so intimately related, microbiome and STIs, that it felt like we were missing a big part of the picture by not supporting people in both areas.”  The new funding round will be used to expand Evvy’s at-home testing and care platform, leverage artificial intelligence to explore molecular signatures for female health diagnosis and validate improved outcomes in fertility and pregnancy. Investor Left Lane Capital led the series A round with participation from General Catalyst, Labcorp Venture Fund, RH Capital, Ingeborg Investments, G9 Ventures, Virtue and Amboy Street Ventures. With Evvy’s new investor Labcorp, the health tech company hopes to leverage the raw data it has already acquired to determine whether there are specific markers that could point to novel point-of-care testing.  Evvy’s new STI offering will screen for a range of common STIs, including chlamydia, gonorrhea and trichomoniasis. STIs have seen a steady increase in recent years. From 2017 to 2021, cases of gonorrhea increased roughly 28%, cases of syphilis grew by almost 74% and cases of congenital syphilis jumped by more than 203%. Patients seeking STI testing with vaginal microbiome health in mind can access the provider directly or be referred to Evvy by their primary care physician or OB-GYN. At-home tests allow for the development of personalized treatment along with the expansion of data, filling what Jain calls the “gender health research gap.”  “We started with the data, with only the test,” Jain said. “We started with only what was classified as vaginitis in the healthcare system. There’s one ICD-10 code for all of vaginitis. We were seeing 70 different permutations of the specific microbes that were present and how that related to whether the patient was in menopause or postpartum. Turns out precision medicine requires data.”  A miniscule 4% of overall funding for research and development for healthcare products and services goes to women’s health.  Evvy has also seen trends of patients unable to find support in the larger medical system when addressing bacterial vaginosis (BV), the most common cause of vaginal symptoms among women.  It is estimated that the prevalence of BV among women between the ages of 14 to 49 is 29.9%, according to the Centers for Disease Control and Prevention. Despite the prevalence of the infection, research has yet to determine how sexual activity affects the development of vaginal symptoms although it has been found to rarely affect those who are not sexually active.  Those with untreated BV have been found to have an increased chance of getting an STI. Pregnant people with untreated BV are more likely to give birth early and have a baby at a low birth weight. The vaginal microbiome has also been tied to gynecological cancers.  “We’re thinking about how our platform can be leveraged in these specific cases where we know the vaginal microbiome plays a role,” Jain said. “When it comes to things like fertility and pregnancy, we know that having a healthy vaginal microbiome is associated with better outcomes.”  Single tests come in at $129 and give a snapshot of a patient’s vaginal microbiome. Patients can also become members for a fee of $99 a test for four annual tests in order to track vaginal health changes. Each test includes access to one-on-one virtual coaching. An additional panel identifying STIs, the presence of 11 vaginal microbes and 17 antibiotic-resistance genes can be added to any test for an additional $119. These tests return results faster, between one and three days, as patients wait for Evvy's other tests, which can take seven to 10 days to garner results.  If a patient is determined to have a vagina in dysbiosis, Evvy physicians design a treatment plan including supplements or medication for patients in addition to two calls with a certified health coach.   An Evvy IRB-approved study (PDF) found that within two months of treatment, 83% of participants acquired a healthy microbiome, 96% of patients determined their treatment to be effective and 100% said their symptoms improved. There's a growing list of startups focused on women's health, targeting everything from pregnancy and fertility to menopause. And there are now a handful specifically targeting vaginal health, such as at-home vaginal microbiome testing company Juno Bio and Stix, which offers UTI and yeast infection treatments. Wisp is another online sexual health company, while Hims & Hers also offers sexual health testing and care for women.