The US Food and Drug Administration (FDA) has approved Merck's Noxafil (posaconazole) 100 mg delayed-release tablets.
The tablets are a new formulation with a loading dose of 300mg (three 100mg delayed-release tablets) twice daily on the first day, followed by a once-daily maintenance dose of 300mg starting on the second day of therapy.
The company also markets Noxafil (40mg/mL) oral suspension, which is dosed three times daily.
Both tablets and oral suspension are intended for the prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised.
The infections include hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia (low white blood cell counts) from chemotherapy.
The approval is based a non-comparative, multicenter trial designed to assess the pharmacokinetic properties, safety and tolerability of the tablets in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who had developed or were anticipated to develop significant neutropenia.
Patients, who had undergone HSCT and were receiving immunosuppressive therapy for prevention or treatment of GVHD, were also involved in the trail.
The company said that two clinical trials of prophylaxis against invasive fungal infections were conducted with Noxafil oral suspension, which showed substantially fewer breakthrough infections caused by Aspergillus species in patients receiving posaconazole prophylaxis compared to patients receiving fluconazole or itraconazole.
According to the company, Noxafil should not be given to persons allergic to posaconazole, any ingredients of the drug, or other azole antifungal medicines, and also the administration of the drug with sirolimus, pimozide, quinidine, atorvastatin, lovastatin, simvastatin and ergot alkaloids should be avoided.
