Noxafil (Posaconazole) 100 mg Gastro-Resistant Anti-Fungal Tablet Formulation Launched in the UK

MSD (Merck Sharp & Dohme Ltd) has announced the UK launch of Noxafil  (posaconazole) 100 mg gastro-resistant tablets, a new formulation offering the antifungal efficacy of posaconazole 40 mg/mL oral suspension with the convenience of once-daily dosing after twice-daily dosing on the first day. This follows the European Commission approval granted on 23 April 2014.

Posaconazole tablets are administered without regard to food intake, as a loading dose of 300 mg (three 100 mg tablets) twice a day on the first day of therapy, followed by three 100 mg tablets once daily thereafter. The same tablet regimen is used for either prophylaxis or treatment. Duration of therapy is determined by the severity of the underlying disease, recovery from immunosuppression and clinical response and, in the case of prophylaxis, continued for 7 days after the neutrophil count rises above 500 cells per mm3.

“This is a step forward for the prophylaxis and treatment of fungal disease,” said Professor Antonio Pagliuca, Department of Haematological Medicine, King's College Hospital, London. “The new tablet formulation will ensure patients get appropriate therapeutic levels of the drug due to its consistent absorption.”

The burden of invasive fungal disease (IFD) continues to increase as a result of improved medical intervention and supportive care. The growing number of patients with a variety of risk factors such as transplantation, chemotherapy, HIV infection, use of corticosteroids or new immunosuppressive agents, have caused an increase in incidence of invasive infections in recent years.

Fungal infections are a significant source of morbidity especially in immunocompromised patients, with attributable mortality from invasive fungal infections (IFIs) ranging from 60–90% for invasive aspergillosis and exceeding 80% for invasive zygomycosis and fusariosis. The precise prevalence of invasive fungal infections is not known but population-based surveillance estimates it at 12 to 17 per 100,000 population in England and Wales.