FDA Approves Itraconazole Formulation for Systemic Fungal Infections

DECEMBER 12, 2018
Kevin Kunzmann
FDAThe US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) of SUBA-itraconazole (Tolsura) 65 mg capsules for the treatment of systemic fungal infections in adult patients.

The new itraconazole formulation, from Mayne Pharma Group, was approved for patients with blastomycosis, histoplasmosis, and aspergillosis—infections most commonly associated with immunocompromising diseases such as HIV/AIDS or chronic rheumatic disorders. They are frequently associated with long-term health issues, or even high mortality rates.

In particular, the indication is mean for both pulmonary and extrapulmonary blastomycosis; histoplasmosis including chronic cavitary pulmonary disease and non-meningeal histoplasmosis; and both pulmonary and extrapulmonary aspergillosis in patients intolerant or refractory to amphotericin B therapy.

In a statement accompanying the announced NDA approval, Mayne Pharma chief executive officer Scott Richards noted that SUBA-itraconazole was shown in clinical trials to have increased bioavailability and significantly reduced variability versus oral itraconazole capsules.

“We are very pleased to have received FDA approval of this patented formulation of itraconazole which incorporates Mayne Pharma's proprietary SUBA technology to improve the bioavailability of poorly soluble drugs,” Richards said. “Reformulation of existing drugs plays an important role in improving patient compliance and clinical outcomes.”

According to Mayne Pharma, the drug will be commercialized and marketed starting in January 2019, with a primary focus on hospital-based infectious disease specialists. The NDA marks Tolsura as among the 60-plus products currently marketed by the company in the US.

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