Evaluation of the market and availability of vaginal gels with aminopeptide complexes for the treatment of HPV-associated diseases
DOI:
https://doi.org/10.24959/nphj.26.210Keywords:
soft dosage forms; pharmaceutical development; aminopeptide complexes; vaginal gels; marketing analysis.Abstract
The increasing prevalence of papillomavirus infection (HPV) and its role in the development of cervical precancerous and inflammatory diseases cause increased interest in adjunctive and non-invasive approaches to the treatment and prevention of recurrence. Vaginal gels based on aminopeptide complexes occupy a separate segment of the pharmaceutical market and are positioned as agents for the local immunomodulation and stimulation of mucosal regeneration.
Aim. To conduct a comprehensive analysis of the market, regulatory status, and affordability of vaginal gels with amino peptide complexes (in particular, alloferon) in Ukraine.
Materials and methods. The content analysis of official websites of manufacturers, pharmacy network websites, and online pharmacies; the comparative price analysis; the analysis of patient information leaflets, scientific publications, and data from scientific databases were applied.
Results. The market for topical agents for the treatment of HPV-associated pathologies is characterized by high heterogeneity by the composition, mechanisms of action, regulatory status, and evidence level. Dysplagel is the one and only product in the study sample that has an aminopeptide complex (aloferon). The declared mechanism of its action is based on the concept of the local peptide immunomodulation using a liposomal delivery system, but the evidence base for its effectiveness is limited mainly to local studies and does not meet the requirements for medicines in accordance with EMA and FDA standards. The analysis has revealed the high cost and significant interregional variability in the prices and availability of the medicinal product studied, which leads to low economic accessibility and an increased risk of treatment discontinuation.
Conclusions. Amino-peptide vaginal gels, in particular aloferon-based products, have the potential for the local immunomodulation in HPV-associated lesions and can be used as an adjunct to active surveillance strategies for low-grade diseases, provided that the principles of evidence-based medicine are followed and patients are properly informed, which makes further research and development in this scientific field relevant.
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