Fusafungine
Also known as: Bioparox, Fusafungina, Fusafungine, Locabiosol, Locabiotal, Rhinofluimucil
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Summary
Fusafungine is a cyclic depsipeptide mixture derived from fungi and marketed as a prescription nasal or oropharyngeal spray for upper respiratory tract infections. It has been used to treat acute laryngitis, follicular pharyngitis, and post‑tonsillectomy discomfort, aiming to combine local antibacterial and anti‑inflammatory effects.
Mechanism of Action
Fusafungine exhibits bacteriostatic activity against a range of respiratory pathogens and modulates the local inflammatory response in the nasal and pharyngeal mucosa. By targeting the early tissue reaction, it reduces vascular leakage and cytokine‑mediated irritation while preserving the airway’s natural antibacterial and antiviral defenses. The exact molecular targets have not been detailed in the published literature.
What the Research Shows
Clinical evidence for fusafungine comes from a handful of small trials and one Cochrane review. An open, multicentre study of 166 adults with community‑acquired upper respiratory infections reported significant symptom reduction and high physician satisfaction after 7–10 days of spray use. A double‑blind, placebo‑controlled trial in 81 patients with follicular pharyngitis found modest improvements in symptoms and post‑nasal drip, approaching statistical significance. In acute laryngitis, a Russian RCT (93 participants) showed a higher clinical cure rate at day five (RR 1.5) for fusafungine versus no treatment, though later time points showed no difference. A post‑tonsillectomy study (68 patients) observed early pain relief and reduced analgesic use. The Cochrane review highlighted very low‑quality evidence for antibiotics in acute laryngitis, noting the modest day‑5 benefit of fusafungine but emphasizing methodological limitations.
Reported Benefits
Available data suggest fusafungine can provide rapid relief of nasal and throat symptoms in upper respiratory infections, improve early clinical cure rates in acute laryngitis, and lessen postoperative pain after tonsillectomy. Tolerability was reported as good in open and double‑blind studies, with most patients requiring no additional therapy.
Limitations of the Evidence
Evidence is limited to small, often open‑label or modestly powered trials with risk of bias; the Cochrane review classified the overall evidence as very low quality. Objective voice outcomes in laryngitis were not improved, and benefits beyond the first week were not sustained. The product has been withdrawn, so contemporary data and regulatory status are lacking.
Safety Considerations
Across the published studies fusafungine was described as well tolerated, with no serious adverse events reported. Local irritation is a theoretical risk with any nasal or oropharyngeal spray, but specific safety signals were not documented in the abstracts. The limited sample size and withdrawal of the product mean that rare adverse effects may be under‑recognized.
How It Is Administered
Fusafungine was administered as a metered‑dose spray to the nose or throat, typically six times daily for acute laryngitis or three to four times daily after tonsillectomy. Treatment courses ranged from 7 to 10 days in the reported trials.
Routes of Administration
Goals & Uses
- Relief of nasal congestion and rhinorrheaSymptom ReliefModerate
- Treatment of acute pharyngitisENT/infectious DiseaseLow
- Local anti-inflammatory effect in upper airwaysAnti InflammatoryLow
- Treatment of acute rhinitis/sinusitisENT/infectious DiseaseLow
- Treatment of laryngitisENT/infectious DiseaseLow
Contraindications
- Known hypersensitivity to fusafungine or any component of the formulationAllergyHigh
- Children under 30 months of agePediatricHigh
- Severe asthma or chronic obstructive pulmonary diseaseRespiratoryModerate
- History of hypersensitivity to fusafungine or enniatinsAllergy/immunologyHigh
- Pregnancy (especially first trimester)ReproductiveModerate
- Asthma or severe bronchospasmRespiratoryHigh
Adverse Effects
- Nasal irritation / burning sensationLocalCommon
- AnaphylaxisImmunologicRareSevere life-threatening allergic reaction
- SneezingLocal ReactionCommon
- Epistaxis (nosebleed)Local/NasalUncommon
- BronchospasmRespiratoryRare
- Dysgeusia (altered taste)SensoryUncommon
- Anaphylaxis / severe hypersensitivityImmunologicRare
- Local nasal/throat irritationLocal ReactionCommon
- Urticaria / skin rashDermatologicUncommon
Drug Interactions
- Other inhaled corticosteroidsLow
Population Constraints
- Elderly patients with reactive airwaysGeriatricRelative
- Patients with atopic history or asthmaAllergy/respiratoryRelative
- Pediatric patients under 30 monthsPediatricAbsolute
- Pregnant or breastfeeding womenReproductiveRelative
- Children under 12 yearsAgeRelative
- Pregnant womenReproductiveRelative
Regulatory Status
- European UnionWithdrawnApproved: acute rhinitisWithdrawn in 2016 due to severe allergic reactions
- United StatesUnapprovedNever submitted for FDA approval
- United KingdomWithdrawnApproved: Upper respiratory tract infectionsFollowed EMA withdrawal decision; no longer marketed.
Withdrawn in the EU (2016) and many other jurisdictions because of risk of serious hypersensitivity reactions; never approved in the United States.
Evidence & Sources
- Journal ArticleModerateZhao P, et al.2019-01-01T00:00:00.000000Z
- Journal ArticleHighReveiz L, Cardona AF2015-01-01T00:00:00.000000Z
- Journal ArticleModerateGerman-Fattal M, Mösges R2004-01-01T00:00:00.000000Z
- Journal ArticleModerateKroslák M2002-01-01T00:00:00.000000Z
- Journal ArticleModeratePandraud L2002-01-01T00:00:00.000000Z
- Journal ArticleModerateLukan N2002-01-01T00:00:00.000000Z
Frequently Asked Questions
What conditions has fusafungine been studied for?
Clinical trials have examined fusafungine for community‑acquired upper respiratory tract infections, acute laryngitis, follicular pharyngitis, and postoperative pain after tonsillectomy, using a local spray applied to the nasal or oropharyngeal mucosa.
Is fusafungine still available as a medication?
According to the structured data, fusafungine’s status is "withdrawn," indicating it is no longer marketed or approved for clinical use in most jurisdictions.
How does fusafungine differ from systemic antibiotics?
It is delivered locally as a spray, allowing high concentrations at the site of infection while minimizing systemic exposure. It combines bacteriostatic activity with anti‑inflammatory effects, unlike many systemic antibiotics that lack direct anti‑inflammatory properties.
Are there any known serious side effects?
Published studies reported good tolerability and no serious adverse events. The most likely local adverse effect would be irritation of the nasal or throat mucosa, but specific safety data are limited.
What does the evidence say about its effectiveness?
Small trials suggest symptom relief and a modest early cure benefit in acute laryngitis, but the overall quality of evidence is low, with inconsistent findings beyond the first few days of treatment.
What is Fusafungine?
Fusafungine is a cyclic depsipeptide mixture derived from fungi and marketed as a prescription nasal or oropharyngeal spray for upper respiratory tract infections. It has been used to treat acute laryngitis, follicular pharyngitis, and post‑tonsillectomy discomfort, aiming to combine local antibacterial and anti‑inflammatory effects.
What is Fusafungine used for?
Fusafungine is educationally associated with: Relief of nasal congestion and rhinorrhea, Treatment of acute pharyngitis, Local anti-inflammatory effect in upper airways, Treatment of acute rhinitis/sinusitis, Treatment of laryngitis. Educational only — not medical advice.
How is Fusafungine administered?
Recorded routes of administration: Intranasal, Nasal, Oropharyngeal Inhalation.
What are the potential side effects of Fusafungine?
Reported adverse effects include: Nasal irritation / burning sensation, Anaphylaxis, Sneezing, Epistaxis (nosebleed), Bronchospasm, Dysgeusia (altered taste), Anaphylaxis / severe hypersensitivity, Local nasal/throat irritation, Urticaria / skin rash. This list is not exhaustive — consult a qualified clinician.
Who should avoid Fusafungine?
Recorded contraindications: Known hypersensitivity to fusafungine or any component of the formulation, Children under 30 months of age, Severe asthma or chronic obstructive pulmonary disease, History of hypersensitivity to fusafungine or enniatins, Pregnancy (especially first trimester), Asthma or severe bronchospasm. Consult a qualified clinician before use.