FDA Accepts NDA for Mayne Pharma's SUBA-Itraconazole Capsule for Fungal Infections


The unique formulation of SUBA-Itraconazole capsules, which has improved bioavailability and significantly reduced variability, represents a substantial innovation.

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Mayne Pharma Group Limited announced that the US Food and Drug Administration (FDA) accepted for review the new drug application for SUBA-Itraconazole capsules in treatment of 3 systemic fungal infections: histoplasmosis, blastomycosis and refractory aspergillosis.

The serious, potentially life-threatening fungal infections commonly occur in those with a history of immunosuppressant treatment, cancer, transplants or HIV/AIDS. Due to the underlying conditions, it’s often difficult to achieve target blood levels of itraconazole with conventional oral itraconazole preparations.

The FDA review is expected to be completed in the beginning of 2019.

“The conventional formulation of oral itraconazole suffers from poor and unpredictable bioavailability resulting in significant inter- and intra-patient variability, which is a frustration to prescribers,” Scott Richards, chief executive officer, Mayne Pharma, said in a statement. “The unique formulation of SUBA-Itraconazole capsules, which has improved bioavailability and significantly reduced variability to existing products, represents a significant innovation.”

SUBA-Itraconazole, an improved formulation of itraconazole, has enhanced bioavailability and significantly reduced variability versus the originator, providing enhancements to patients and prescribers, offering a more predictable clinical response and enabling a reduction in active drug quantity to deliver the required therapeutic blood levels.

The capsules do not need to be taken with food and can be co-administered with drugs that lower gastric acidity without reduction in itraconazole bioavailability, which increases patient convenience.

Itraconazole can be used to treat both superficial infections of the skin and nail, as well as systemic fungal infections of the major organs, as it’s one of the broadest spectrum antifungal drugs.

Mayne Pharma received regulatory approval for SUBA-Itraconazole capsules in Australia, Argentina, Belgium, Germany, Mexico, Italy and Spain, and is seeking approval in other countries.

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