NOXAFIL NEWS HIGHLIGHTS
Published Studies Related to Noxafil (Posaconazole)
Posaconazole: an extended-spectrum triazole antifungal agent. [2007.09]
BACKGROUND: The incidence of invasive fungal infections (IFIs) caused by opportunistic filamentous molds is increasing, along with emerging fungal resistance. Posaconazole [generic for Noxafil], a structural analogue of itraconazole that was approved for marketing in the United States in 2006, appears to be a promising antifungal agent. OBJECTIVE: This article provides an overview of the pharmacology, efficacy, and tolerability of posaconazole when used for the prophylaxis and treatment of various common and rare fungal infections... CONCLUSIONS: Posaconazole suspension administered at up to 800 mg/d is a reasonable alternative to conventional antifungal agents for the prevention and treatment of IFIs in high-risk populations. It may also be suitable in patients with infections caused by rare or relatively resistant fungi, and those who are unable to tolerate long-term therapy with other antifungal agents.
Posaconazole plasma concentrations in juvenile patients with invasive fungal infection. [2007.03]
Posaconazole [generic for Noxafil] is an orally bioavailable triazole antifungal agent for the treatment and prophylaxis of invasive fungal infection. We evaluated plasma posaconazole concentration data from juvenile (younger than 18 years; n = 12) and adult (18 to 64 years; n = 194) patients who participated in a multicenter, phase 3, open-label study that assessed the efficacy and safety of posaconazole treatment for persons who were intolerant of or had invasive fungal infection refractory to standard antifungal therapies...
Posaconazole vs. fluconazole or itraconazole prophylaxis in patients with neutropenia. [2007.01.25]
BACKGROUND: Patients with neutropenia resulting from chemotherapy for acute myelogenous leukemia or the myelodysplastic syndrome are at high risk for difficult-to-treat and often fatal invasive fungal infections... CONCLUSIONS: In patients undergoing chemotherapy for acute myelogenous leukemia or the myelodysplastic syndrome, posaconazole [generic for Noxafil] prevented invasive fungal infections more effectively than did either fluconazole or itraconazole and improved overall survival. There were more serious adverse events possibly or probably related to treatment in the posaconazole group. (ClinicalTrials.gov number, NCT00044486 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.
Posaconazole or fluconazole for prophylaxis in severe graft-versus-host disease. [2007.01.25]
BACKGROUND: Invasive fungal infections are an important cause of morbidity and mortality after allogeneic hematopoietic stem-cell transplantation... CONCLUSIONS: Posaconazole [generic for Noxafil] was similar to fluconazole for prophylaxis against fungal infections among patients with GVHD. It was superior in preventing invasive aspergillosis and reducing the rate of deaths related to fungal infections. (ClinicalTrials.gov number, NCT00034645 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.
Effect of a nutritional supplement on posaconazole pharmacokinetics following oral administration to healthy volunteers. [2006.05]
We conducted a randomized, crossover study in healthy adults to examine the effects of a nutritional supplement (Boost Plus) on posaconazole [generic for Noxafil] pharmacokinetics. In this study, coadministration of posaconazole with Boost Plus increased the maximum concentration of posaconazole in serum and area under the concentration-time curve from 0 to 72 h values 3.4- and 2.6-fold, respectively, compared to those for the fasted state..
Clinical Trials Related to Noxafil (Posaconazole)
A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2) [Active, not recruiting]
Limited Access Protocol of Posaconazole in Invasive Fungal Infections Study PO2095 [Terminated]
Therapeutic options for serious fungal infections are limited by intrinsic and acquired
resistance to existing antifungal agents. For example, zygomycetes (such as Mucor spp.) are
intrinsically resistant to voriconazole and caspofungin. Yet, the only available therapeutic
option, amphotericin, is associated with significant renal toxicity, even in lipid
formulations. Posaconazole is a new antifungal drug, not yet Food and Drug Administration
(FDA) approved, but which has excellent in vitro activity against some intrinsically
resistant fungi such as the zygomycetes.
The intent of this trial is to provide access to posaconazole to patients with serious fungal
infections which are refractory to standard antifungal therapies or invasive fungal
infections for which there are currently no effective therapies. Secondly, the drug will
also be made available to patients with invasive fungal infections who:
- have experienced serious or severe toxicities while receiving standard antifungal
therapies;
- have pre-existing renal dysfunction which precludes use of standard antifungal
therapies; or
- are chronically immunosuppressed with a history of invasive fungal infections previously
treated with posaconazole in other clinical trials, and who require oral antifungal
suppressive therapy as maintenance treatment to prevent recurrence.
This is a multicenter, open-label, non-comparative experimental treatment use protocol. The
experimental treatment use protocol will provide the investigational medication posaconazole
where no other drug is commercially available. Posaconazole is given as an orally or
enterally administered suspension. The duration of therapy is at the discretion of the
investigator. Safety assessments will include an electrocardiogram [ECG] (to ensure no QTc
interval prolongation) performed at baseline and serum/urine pregnancy testing performed at
baseline and every three months after initiation of therapy. Plasma concentrations will be
obtained if there is evidence of clinical failure. No other tests will be performed
specifically for the experimental treatment use protocol.
Postmarketing Surveillance Study on the Labeled Use of Oral Posaconazole 40 mg/mL Suspension (Study P04641) [Recruiting]
Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC) [Recruiting]
The objective of this study is to compare the safety and efficacy of ABLC versus oral
Posaconazole in the prevention of invasive fungal infections in high risk patients with
hematologic malignancies or hematopoietic stem cell transplant.
Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir [Recruiting]
The purpose of this study is to determine the influence of posaconazole on unboosted
fosamprenavir pharmacokinetics, and vice versa, in healthy volunteers. A second objective is
to determine the safety of combined use of fosamprenavir with posaconazole in healthy
volunteers.
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