Thursday, 13 September 2012

Intravenous posaconazole passes key test in patients

Whilst oral posaconazole has been licensed since 2006, development of an intravenous formulation has been challenging and slow.
At the recent ICAAC meeting in San Francisco, Professor Johan Maertens and colleagues from Leuven, Belgium and collaborators in Germany described the pharmacokinetics of 2 doses of intravenous (IV)  posaconazole. The 55 patient volunteers all had leukaemia and low white cell counts and were given IV posaconazole to prevent fungal infection. Usually oral posaconazole is administered but this is often poorly absorbed and so can be ineffective. Maertens compared 200mg and 300mg given once daily and found good tolerance and higher protective blood levels of posaconazole from the 300mg dose. The average blood level at 14 days was 1430ng/ml which is associated with good efficacy and protection, the minimum effective level was seen in 95% of patients. Posaconazole is formulated in a novel cyclodextrin product for IV use, similar to voriconazole and itraconazole.

Merck supported this study and will now advance IV posaconazole into randomised clinical studies. This complements a parallel development of an oral tablet of posaconazole.  Since posaconazole is the most broad spectrum antifungal available, limited primarily by poor bioavailablity in highly susceptible patients and occasional resistance, these formulation improvements will help to deliver improved therapy for many patients.

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