Breakthrough Clinical Results
Saptalis Pharmaceuticals announced the launch of LIKMEZ® (metronidazole) oral suspension, the first and only US FDA-approved ready-to-use oral liquid formulation of metronidazole. This innovative liquid formulation is designed for patients who have difficulty swallowing or taste sensitivities. LIKMEZ® addresses common adherence challenges associated with traditional metronidazole formulations by offering accurate dosing and a pleasant strawberry-peppermint flavor. It's approved for treating trichomoniasis, anaerobic bacterial infections in adults, and amebiasis in adults and pediatric patients. The product is protected by two U.S. patents and will be available through major wholesalers and retail pharmacies.
Key Highlights
- Launch of LIKMEZ®, the first and only FDA-approved ready-to-use oral metronidazole suspension.
- Addresses challenges of swallowing difficulties and taste sensitivities associated with traditional metronidazole.
- Approved for treating trichomoniasis, anaerobic bacterial infections, and amebiasis.
- Features a pleasant strawberry-peppermint flavor and does not require refrigeration.
Incidence and Prevalence
The most recent global estimates for trichomoniasis prevalence and incidence come from the 2016 World Health Organization study.
2016 Global Estimates:
- Prevalence (Women aged 15-49): 5.3% (95% uncertainty interval, UI: 4.0-7.2)
- Prevalence (Men aged 15-49): 0.6% (95% UI: 0.4-0.9)
- Incident Cases: 156.0 million (95% UI: 103.4-231.2 million)
Earlier Estimates:
While the 2016 estimates are the most recent comprehensive global figures, several studies provide estimates for different years and populations. It's important to note that methodologies and data availability can influence these estimates, leading to variations between studies.
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2012 (WHO):
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Prevalence (Women 15-49): 5.0% (95% UI: 4.0-6.4%)
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Prevalence (Men): 0.6% (95% UI: 0.4-0.8%)
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Incident Cases: 143 million (98-202 million)
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2018 (US):
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Prevalence (Ages 15-59): 2.6 million (Q1, 2.4; Q3, 2.7)
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Incidence (Ages 15-59): 6.9 million (Q1, 6.2; Q3, 7.6)
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This study highlights the age distribution, with higher prevalence and incidence in older age groups.
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2000 (WHO):
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Global Cases (Adults 15-49): 170 million
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US Adolescent Study:
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Prevalence (Females 13-19): 14.4% (95% CI, 11.3-17.5)
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Incidence: 22.1 cases per 100 person-years
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This study demonstrates the high burden of trichomoniasis in specific populations, such as adolescents.
Key Considerations:
- Data Gaps: Estimates for many regions and countries are based on limited data, highlighting the need for more robust surveillance and research.
- Methodological Variations: Different study methodologies and case definitions can influence prevalence and incidence estimates.
- Asymptomatic Infections: Trichomoniasis is often asymptomatic, particularly in men, which can lead to underestimation of the true burden of infection.
- Health Disparities: Certain populations, such as African Americans in the US, experience disproportionately higher rates of trichomoniasis.
In summary, while the 2016 WHO estimates provide the most recent global figures, it's crucial to consider the context of earlier studies and the limitations of available data when interpreting the burden of trichomoniasis.
Drug used in other indications
Metronidazole, initially introduced for trichomoniasis, has expanded its therapeutic applications to various other conditions. Here's a summary of other indications where metronidazole is being used or trialled, along with the intervention models employed in these trials:
1. Bacterial Vaginosis (BV): * Intervention Models:
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Comparison with other antibiotics: Metronidazole's efficacy for BV has been compared with other antibiotics like clindamycin (oral and intravaginal) and tinidazole. Studies have explored different doses and durations of metronidazole treatment, including single-dose vs. multi-dose regimens, and compared their efficacy and side effect profiles. One study compared 2% clindamycin vaginal cream with oral metronidazole and found similar efficacy (78-83%). Another study compared different doses of tinidazole with metronidazole and found no significant difference in cure rates or side effects. A study also evaluated single-dose metronidazole vaginal gel (1.3%) compared to a vehicle gel and found it to be safe and more effective in curing BV.
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Combination with probiotics: Studies have investigated the use of probiotics in conjunction with metronidazole to enhance treatment success and reduce recurrence rates of BV. One study found that adding probiotics to metronidazole therapy increased the likelihood of cure from BV (63.6% vs. 11.9% in the placebo group).
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Alternative treatments for resistant BV: For recurrent BV, extended courses of metronidazole, metronidazole vaginal gel, clindamycin, and tinidazole have been studied. Emerging research explores biofilm disruption, probiotics, prebiotics, and botanical treatments, although further studies are needed.
2. Giardiasis: * Intervention Models:
- Comparison with other drugs: Tinidazole has shown higher parasitological cure rates compared to metronidazole and albendazole in network meta-analyses. Other alternatives like paromomycin, nitazoxanide, and benzimidazoles have also been explored. A systematic review of randomized controlled trials found that 5-nitroimidazoles, including metronidazole, had a slightly better efficacy compared to controls in treating giardiasis.
3. Amoebiasis: * Intervention Models:
- Comparison with other drugs: Tinidazole has demonstrated higher efficacy compared to metronidazole in some trials.
4. Anaerobic Infections (Including Oral Anaerobic Infections): * Intervention Models:
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Oral metronidazole monotherapy: Studies have evaluated the use of oral metronidazole alone for various anaerobic infections, including pericoronitis, necrotizing oral infections, acute periapical infection, and cellulitis. Dosages and durations vary depending on the specific infection. However, evidence supporting its use in deep tissue infections like osteomyelitis is limited.
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Metronidazole in combination with other antibiotics: Metronidazole is often combined with other antibiotics, especially in mixed aerobic/anaerobic infections. For instance, it's used in combination regimens for intra-abdominal infections and pelvic infections. A study found that combining metronidazole with ciprofloxacin was slightly more potent against Clostridium species than either drug alone.
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Prophylaxis: Metronidazole is used prophylactically before surgical procedures, particularly those involving the bowel, to prevent anaerobic infections.
5. Helicobacter pylori Infections: * Intervention Models:
- Combination therapy: Metronidazole is commonly used in combination with other antibiotics (e.g., amoxicillin, clarithromycin) and proton pump inhibitors (e.g., omeprazole) for H. pylori eradication. Studies have evaluated different combinations and durations of treatment. One study compared metronidazole-containing regimens with metronidazole-free regimens after the failure of first-line triple therapy and found that metronidazole-containing regimens had higher eradication rates.
6. Other Indications: * Rosacea: Oral metronidazole is used for treating rosacea. * Crohn's Disease: Metronidazole can be used to treat Crohn's disease. * Clostridium difficile Colitis: Metronidazole is a preferred agent for treating C. difficile colitis, often compared with vancomycin in terms of efficacy and cost-effectiveness. One study found that in patients 65 years of age or younger with mild CDI, clinical outcomes were similar with metronidazole and vancomycin.
It's important to note that the specific dosages, durations, and combination regimens for metronidazole vary depending on the indication and individual patient factors. Furthermore, research is ongoing to explore new uses and optimize treatment strategies for metronidazole in various conditions.