Delving into the Latest Updates on Nystatin/Neomycin Sulphate/Polymyxin B Sulphate with Synapse

Overview

Basic Info

Drug Type

Polypeptide antibiotic

Synonyms

nystatin/neomycin sulphate/polymyxin B sulphate, Polygynax

Target

Ergosterol x PBPs

Action

modulators, inhibitors

Mechanism

Ergosterol modulators(Ergosterol modulators), PBPs inhibitors(Bacterial penicillin-binding protein inhibitors), Cell membrane function inhibitors

Therapeutic Areas

Urogenital Diseases

Active Indication

Vaginitis

Inactive Indication

Bacterial VaginosisInfective vaginitis

Originator Organization-

Active Organization

Laboratoire INNOTECH International SAS

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Rwanda (11 Feb 1997),

Vaginitis

Regulation-

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Structure/Sequence

Molecular FormulaC23H46N6O13

InChIKeyPGBHMTALBVVCIT-VCIWKGPPSA-N

CAS Registry119-04-0

View All Structures (2)

POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated for the local treatment of vaginitis due to sensitive germs and treatment of non specific vaginitis of adults. POLYGYNAX® has been marketed in France since 1969.
Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study supporting the interest of the combination of antifungal and antibiotics agents versus antifungal agent alone.
The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole in the treatment of women experiencing symptoms of infectious vaginitis.

Start Date01 Sep 2015

Sponsor / Collaborator

Laboratoire INNOTECH International SAS

[+1]

NCT02444481

/ CompletedPhase 4

Open Multicenter Clinical Study of the Efficacy of the Local Treatment With Polygynax of Mycotic and/or Bacterial Vaginitis

Open prospective multicenter phase IV study in patients presenting with symptoms of bacterial and/or mycotic (mushroom) vaginitis for 12 days as specified in the product information.
Investigators/centers: 20 gynacologists are previewed to do the study in ambulatory treatment.
Objectifs of the study:
Principal objectif:
Evaluation of the efficacy of the treatment on the clinical symptoms of bacterial and/or mycotic vaginitis
Secondary objectif:
Evaluation of the efficacy of the treatment on eradication of the diagnosed germs Evaluation of the correspondence of the efficacy on the symptoms and on the eradication of the germs.
Numbers of patients previewed: 100 patients for evaluation of the efficacy
Criteria of evaluation
Principal criteria:
Clinical efficacy as judged by the investigator Secondary criteria:evaluation of clinical symptoms judged by the patient reduction or emlimination of bacteria and other germs the relationship between clinical and bacterial results
Evaluation of tolerance
Used Study Drug:
Polygynax, vaginal capsule consisting of Polymyxin 35000 UI, Neomycin 35000UI and Nystatin 100000UI Application: vaginal application once daily in the evening for 12 days
Study design:
Visit 1:
All patients presenting with the clinical symptoms, presenting all inclusion criteria and none of the exclusion criteria are included in the study at visit 1 and receive Polygynax treatment (one vaginal capsule once daily in the evening).
A vaginal smear is obtained. Visit 2 (optional) If the results of the bacteriological examination confirms an infection with germs sensible to the treatment with Polygynax the treatment is continued. If other germs not sensible to Polygynax are present, the patients is contacted to stop the treatment, to come back to a second visit to her gynacologist who will change the treatment. The other patients continue the treatment.
Visit 3:
After the treatment the patients come back to the last visit. A clinical evaluation and a vaginal smear for control is obtained.

Start Date01 Apr 2009

Sponsor / Collaborator

Laboratoire INNOTECH International SAS

100 Clinical Results associated with Nystatin/Neomycin Sulphate/Polymyxin B Sulphate

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100 Translational Medicine associated with Nystatin/Neomycin Sulphate/Polymyxin B Sulphate

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100 Patents (Medical) associated with Nystatin/Neomycin Sulphate/Polymyxin B Sulphate

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8

Literatures (Medical) associated with Nystatin/Neomycin Sulphate/Polymyxin B Sulphate

01 Dec 2020·International journal of pediatric endocrinology

Undervirilized male infant with in utero exposure to maternal use of high dose antifungal therapy

Author: Yau, Mabel ; Gujral, Jasmine ; Costin, Gertrude ; Rapaport, Robert ; Sethuram, Swathi ; Romero, Christopher J ; Wilkes, Meredith ; Wallach, Elizabeth ; Khurana, Divya

Abstract:

Background:

Antifungals act on fungal sterols structurally similar to human cholesterol. Ketoconazole reversibly suppresses steroidogenesis by inhibiting cytochrome P450 enzymes and interferes with dihydrotestosterone (DHT) activity by binding to the androgen receptor. Hypospadias was reported in infants exposed to nystatin in utero.

Case presentation:

A male infant exposed to antepartum nystatin presented with severe under-undervirilization and transient adrenal corticosteroid abnormalities. He was born in USA at 31 weeks gestation to a mother treated with vaginal Polygynax capsules (nystatin-100,000 international units, neomycin sulphate-35,000 international units and polymyxin B-35,000 international units) for vaginal discharge in the Ivory Coast. She used approximately 60 capsules between the first trimester until delivery. The infant was born with micropenis, chordee, perineo-scrotal hypospadias and bifid scrotum with bilaterally palpable gonads. The karyotype was 46,XY. No Mullerian structures were seen on ultrasound. Serum 17-hydroxyprogesterone (17 OHP) on newborn screening was high (304 ng/ml, normal < 35). Cortisol response to cosyntropin on the 3rd day of life (DOL) was 10 mcg/ml; the subnormal cortisol response may have resulted from prematurity and the predelivery treatment with betamethasone. The elevation of several adrenal corticosteroids was not consistent with any specific enzymatic defect. Hydrocortisone and fludrocortisone were initiated at another hospital for suspected mild glucocorticoid and mineralocorticoid deficiencies. Genetic screening for adrenal and gonadal developmental defects performed when transferred to our care were normal. All medications were gradually discontinued over 5–8 months. Adrenal and testicular responses to cosyntropin and human chorionic gonadotropin (hCG) were normal at 8 months.

Conclusions:

We report severe undervirilization in a 46,XY infant born to a mother treated with prolonged and high dose nystatin during pregnancy. This presentation suggests that prolonged antepartum use of high dose nystatin could lead to severe but transient defects in androgen synthesis and/or action possibly by acting as an endocrine disruptor. Further studies are warranted to confirm this finding. Thus, endocrine disruptors should be considered in male newborns with atypical genitalia not explained by common pathologies.

01 May 2019·Medecine et maladies infectieusesQ4 · MEDICINE

PRISM study: Comparison of a nystatin-neomycin-polymyxin B combination with miconazole for the empirical treatment of infectious vaginitis

Q4 · MEDICINE

Article

Author: Mas, Y ; Bohbot, J M ; Verrière, F ; Goubard, A ; Lucas, N ; Coatantiec, E ; Aubin, F

OBJECTIVE:

An empirical treatment of infectious vaginitis is justified because of its multiple etiologies, the frequent uncertainty of clinical diagnosis and limits of microbiological analysis. Our aim was to comparatively investigate nystatin-neomycin-polymyxin B combination (NNP, Polygynax^®) and miconazole.

PATIENTS AND METHODS:

In this European multicenter, double-blind PRISM trial, participating women presenting with infectious vaginitis were randomized to receive one vaginal capsule containing either NNP for 12 days or miconazole for 3 days followed by 9 days of placebo.

RESULTS:

The clinical success rate was higher in the NNP group (n=302) than the miconazole group (n=309), with a difference between groups close to statistical significance (91.1% vs. 86.7%, P=0.0906). The risk of treatment failure was 36% lower in the NNP group (odds ratio, 0.64; 95% confidence interval, 0.38-1.07). Vaginal burning on Day 2 and vaginal discharge on Day 4 were significantly less intense in the NNP group than in the miconazole group (39.1 vs. 42.3, P=0.031 and 34.6 vs. 37.6, P=0.031, respectively). Adverse drug reactions were reported by 1.2% and 2.1% of patients in the NNP and miconazole group respectively, with the ratio of adverse drug reactions relative to total adverse events significantly higher in the miconazole group (20.3% vs. 6.9%, P=0.022).

CONCLUSION:

The widespread use of NNP for several decades and its good efficacy and safety profile, as well as the frequent diagnostic uncertainties due to the various pathogens sustain the initiation of this broad-spectrum empirical treatment in infectious vaginitis.

01 Jan 2016·Akusherstvo i ginekologiia

[POLYGYNAX IN THE TREATMENT OF VAGINAL INFECTIONS IN PREGNANT AND NON-PREGNANT WOMEN--CLINICAL EXPERIENCE].

Article

Author: Popovski, K ; Popovski, N ; Nedelkovski, V

Vaginal infections /VI/ represent some of the most common diseases by infection of FGS. The aim of this study is to analyze clinical and bacteriological efficacy of Polygynax in the treatment of vaginal infections and to take into account the correlation between the results of microbiological controls and reduction of clinical symptoms. The study included 100 patients, including 50 pregnant and non-pregnant 50 for a period of 3 months. All of them was diagnosed with vaginitis clinical examination, taken material from vagina for microbiological testing. The studied women was conducted targeted therapy Polygynax 12 capsules, in the form of vaginal capsules for 12 days, after which the sample control microbiology. Behind the subjective complaints of the patient and to reduce them as a result of treatment. The effective implementation of Polygynax 12 capsules is equally good as in non-pregnant and pregnant women. In a summary of the survey data to make relevant analyzes and conclusions from the results.

100 Deals associated with Nystatin/Neomycin Sulphate/Polymyxin B Sulphate

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Vaginitis	Rwanda	Laboratoire INNOTECH International SAS	11 Feb 1997

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bacterial Vaginosis	Phase 3	Czechia	Laboratoire INNOTECH International SAS	01 Sep 2015
Bacterial Vaginosis	Phase 3	France	Laboratoire INNOTECH International SAS	01 Sep 2015
Bacterial Vaginosis	Phase 3	Serbia	Laboratoire INNOTECH International SAS	01 Sep 2015
Bacterial Vaginosis	Phase 3	Slovakia	Laboratoire INNOTECH International SAS	01 Sep 2015
Infective vaginitis	Phase 3	Czechia	Laboratoire INNOTECH International SAS	01 Sep 2015
Infective vaginitis	Phase 3	France	Laboratoire INNOTECH International SAS	01 Sep 2015
Infective vaginitis	Phase 3	Serbia	Laboratoire INNOTECH International SAS	01 Sep 2015
Infective vaginitis	Phase 3	Slovakia	Laboratoire INNOTECH International SAS	01 Sep 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02515656 (PRISM, CTgov)	Phase 3	Infective vaginitis \| Vaginitis \| Bacterial Vaginosis	661	POLYGYNAX® (POLYGYNAX®)	tbuwvkqqhf(vnyyiktwhe) = yusuxepmqy oxtwfxmmzy (ljmmkgczll, sdrjciggwy - ajdfdbfbzg) View more	-	22 Jan 2019
				Placebo+GYNODAKTARIN® (Miconazole + Placebo)	tbuwvkqqhf(vnyyiktwhe) = niqntkgfbw oxtwfxmmzy (ljmmkgczll, vouarezqlq - zvghekscxp) View more