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November 27, 2013

Merck obtains FDA approval for Noxafil delayed-release tablets

Merck has obtained US Food and Drug Administration (FDA) approval for its Noxafil (posaconazole) 100mg delayed-release tablets.

By admin-demo

Merck has obtained US Food and Drug Administration (FDA) approval for its Noxafil (posaconazole) 100mg 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 indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients, aged 13 and older, who are at high-risk of developing these infections due to being severely immunocompromised.

Infections include hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with haematologic malignancies with prolonged neutropenia (low white blood cell counts) from chemotherapy.

"Posaconazole delayed-release tablets offer physicians a way to help protect these critically ill patients against invasive Aspergillus and Candida infections while they are in the hospital and once they return home."

According to the company, Noxafil should not be given to persons allergic to posaconazole, any ingredients of Noxafil, or other azole antifungal medicines, as well as the administration of the drug with sirolimus, pimozide, quinidine, atorvastatin, lovastatin, simvastatin and ergot alkaloids should be avoided.

University of Michigan Comprehensive Cancer Center professor of internal medicine Daniel Couriel said prophylaxis against invasive Aspergillus and Candida infections play a major role in the management of severely immunocompromised patients with haematologic malignancies or hematopoietic stem cell transplant recipients at high-risk for these life-threatening fungal infections.

"Posaconazole delayed-release tablets offer physicians a way to help protect these critically ill patients against invasive Aspergillus and Candida infections while they are in the hospital and once they return home," Couriel said.

The approval is based on a non-comparative, multicentre 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.

The trail was also carried out on patients who had undergone HSCT and were receiving immunosuppressive therapy for prevention or treatment of GVHD.

So far, two clinical trials of prophylaxis against invasive fungal infections were carried out with Noxafil oral suspension, which showed substantially fewer breakthrough infections caused by Aspergillus species in patients receiving posaconazole prophylaxis compared with patients receiving fluconazole or itraconazole.

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