To prevent and treat anaerobic infections, new antibiotics are approved for marketing

▎Editor of WuXi AppTec's content team recently, the antibiotic, Levoornidazole Disodium Phosphate for Injection (trade name: Xinrui®), was approved for marketing by the National Medical Products Administration (NMPA) for the prevention and treatment of anaerobic bacteria infection.

Screenshot source: NMPA official website According to NMPA public information, the product is aimed at the following indications: 1.
It is used to treat infectious diseases caused by a variety of sensitive anaerobes.

Sensitive anaerobic bacteria include Bacteroides fragilis, Bacteroides diundi, Bacteroides ovalifolia, Bacteroides polymorpha, Bacteroides vulgaris, Clostridium, Eubacterium, Peptococcus and Peptostreptococcus, Helicobacter pylori, Bacteroides melanogaster , Fusobacterium, CO2 weaving bacterium, Bacteroides gingivalis, etc.

Infectious diseases include (1) abdominal infection: peritonitis, intra-abdominal abscess, liver abscess, etc.
; (2) pelvic infection: endometritis, uterine myositis, fallopian tube or ovarian abscess, pelvic soft tissue infection, Haemophilus vaginitis, etc.
(3) Oral infections: periodontitis, periapical inflammation, pericoronitis, acute ulcerative gingivitis, etc.
; (4) Surgical infections: wound infection, epidermal abscess, decubitus ulcer infection, cellulitis, gas gangrene, etc.
(5) Brain infections: meningitis, brain abscess; (6) severe anaerobic infections such as sepsis and bacteremia.

2.
Prevention of infection before surgery and treatment of anaerobic infection after surgery.

3.
Amoebiasis.

Various forms of histolytic amoebic intestinal infections, including amoebic dysentery.

All forms of amebiasis outside the intestine, especially liver amebiasis with abscess formation.

Picture source: 123RF Ornidazole is a nitroimidazole antibiotic.

This type of antibiotic is a concentration-dependent bactericidal agent, and its bactericidal effect on pathogenic bacteria depends on the peak concentration of the drug.
The higher the concentration, the better the bactericidal effect and the shorter the bactericidal time. As the third-generation nitroimidazole antibiotics after metronidazole and tinidazole, ornidazole has clinical advantages such as definite curative effect, wide applicability, good compliance, and small adverse reactions.
It is widely used clinically in the treatment of anaerobic A variety of diseases caused by infections of bacteria, amoeba protozoa, Giallonia, and Trichomonas.

Due to the modification of the chemical structure, disodium levornidazole phosphate can be quickly converted into levornidazole after intravenous infusion into the human body, which improves the water solubility of the drug and is expected to further reduce adverse reactions.

According to public information, when levornidazole disodium phosphate is administered once a day, the efficacy can be maintained for 24 hours, which improves patient compliance.

Moreover, the pH of the product is close to the pH of human plasma, and the vascular irritation is small, and the patient's medication comfort is higher.

In addition, the effectiveness and safety of levornidazole phosphate disodium have been proven in clinical studies.

In a phase 1 clinical tolerance trial of levornidazole disodium phosphate, a total of 40 healthy subjects completed the trial.

As a result, 7 adverse events occurred, including palpitations, decreased white blood cell count, decreased neutrophils, cough, and pharyngeal discomfort.

However, these adverse events were mild and short in duration.
They all resolved and disappeared spontaneously without intervention, indicating that Levoornidazole Phosphate Disodium for Injection is well tolerated and safe at a dose of 1000mg-3000mg.

Image source: The launch of 123RF Levoornidazole Phosphate Disodium has further enriched the product portfolio for the treatment of anaerobic infections, and brought new treatment options to patients, helping more patients to improve their health and quality of life.

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Reference materials [1] China National Medical Products Administration (NMPA).
Retrieved Jun 1, 2021, from https:// sdxxyp/yppjfb/20210531090806158.
html[2] New breakthrough! Yangtze River Pharmaceutical's first class 1 new chemical drug was approved for marketing.
Retrieved Jun 1, 2021, from https://mp.
weixin.
qq.
com/s/TlTFOxgTIaTZOr1Uhh5c_Q[3] Cao Jiang, Mei Hekun, Bai Nan, etc.
.
Single and multiple intravenous injections of Levoornidazole Disodium Phosphate Phase I Clinical Tolerance Trial in Chinese Healthy Volunteers[C]// Proceedings of the Academic Annual Conference of the Chinese Pharmaceutical Association Drug Clinical Evaluation and Research Professional Committee.
2015.
Note: This article aims to introduce the progress of medical and health research, not to recommend treatment options.

If you need guidance on the treatment plan, please go to a regular hospital for treatment.