Fusafungine

Summary

Fusafungine (marketed as Locabiotal/Bioparox) was a topical polypeptide antibiotic used via inhalation for the local treatment of upper respiratory tract infections (pharyngitis, rhinitis, sinusitis, laryngitis). It was withdrawn from the European market in 2016 by the EMA due to risk of serious hypersensitivity reactions, including bronchospasm and anaphylaxis, which outweighed its modest clinical benefits.

Mechanism of Action

Fusafungine is a mixture of enniatins (cyclic depsipeptides) produced by Fusarium lateritium. It exerts local antibacterial and anti-inflammatory effects by disrupting bacterial cell membrane integrity and inhibiting pro-inflammatory mediator release (e.g., reduced superoxide production by neutrophils). It acts locally on the mucosa of the upper respiratory tract.

Routes of Administration

Goals & Uses

• 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

• Children under 30 months of agePediatricHigh
• History of hypersensitivity to fusafungine or enniatinsAllergy/immunologyHigh
• Pregnancy (especially first trimester)ReproductiveModerate
• Asthma or severe bronchospasmRespiratoryHigh

Adverse Effects

• SneezingLocal ReactionCommon
• 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 womenReproductiveRelative

Regulatory Status

• European UnionWithdrawnApproved: Acute upper respiratory tract infections (pharyngitis, rhinitis, sinusitis, laryngitis)EMA ordered withdrawal in May 2016; risk of serious hypersensitivity reactions outweighed benefit.
• United StatesUnapprovedNever approved by the FDA.
• United KingdomWithdrawnApproved: Upper respiratory tract infectionsFollowed EMA withdrawal decision; no longer marketed.

Withdrawn from EU market in May 2016 following EMA review concluding risk of serious allergic reactions (including anaphylaxis and bronchospasm) outweighs benefits. Never FDA-approved in the US. Withdrawn or unavailable in most jurisdictions.

Evidence & Sources

No sources recorded yet.