FDA Accepts NDA for SUBA-Itraconazole Capsules for Treatment of Systemic Fungal Infections

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

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

Itraconazole has already received approval from the FDA to treat fungal infections; as such, it has been extensively used for that purpose, and, according to HedgePath Pharmaceuticals, Inc., it “has a significant history of safe and effective use in humans.” Mayne Pharma applied their SUBA technology to “the poorly soluble and highly variable” itraconazole to enhance its bioavailability. SUBA-Itraconazole is a “proprietary, patented formulation that enhances solubility and absorption of conventional itraconazole oral formulations,” according to the pharmaceutical company.

“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.”

The enhancements made via the technology is said to offer a more predictable clinical response and enable a reduction in active drug quantity to deliver the required therapeutic blood levels, according to the press release. Furthermore, the capsules do not need to be taken with food and can be co-administered with drugs that lower gastric acidity without a reduction in itraconazole bioavailability, which increases patient convenience.

The indication for the capsules in the United States is for histoplasmosis, blastomycosis, and refractory aspergillosis—all serious, potentially deadly fungal infections that commonly plague individuals who have a history of having been on immunosuppressant treatment, have had cancer, solid organ or bone marrow transplants, or HIV/AIDS. Due to these underlying conditions, it’s hard to reach target blood levels of itraconazole with the conventional form of the drug.

Mayne Pharma has already received regulatory approval for SUBA-Itraconazole capsules in several countries, including Australia, Argentina, Belgium, Germany, Mexico, Italy, and Spain; they are currently seeking approval in other countries as well.

“The US anti-fungal triazole market has a current value of US $500 million according to IQVA and based on the clear unmet clinical need in serious systemic infections, the addressable market is estimated at US $200 million in which SUBA-itraconazole is expected to perform strongly,” according to Mayne Pharma.

A previous version of this article has appeared on MDMagazine.com.