FDA Approves SUBA-Itraconazole for Treatment of Systemic Fungal Infections

The US Food and Drug Administration (FDA) has issued an approval for SUBA-itraconazole (Tolsura), which is indicated for the treatment of certain systemic fungal infections. The new formulation, manufactured by Mayne Pharma, combines the board spectrum antifungal drug itraconazole with a Super-BioAvailable (SUBA) drug delivery platform in a 65mg capsule.

SUBA-itraconazole is indicated for the treatment of blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis), and aspergillosis (pulmonary and extrapulmonary) in patients who are intolerant of or who are refractory to amphotericin B therapy.

Most of these infections occur in vulnerable patient populations, including people living with HIV, individuals with a history of cancer, and individuals who have undergone a solid organ or bone marrow transplants. The azole antifungal is approved for treatment of infections in adult patients.

"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,” Scott Richards, CEO of Mayne Pharma, said in a recent statement. “Reformulation of existing drugs plays an important role in improving patient compliance and clinical outcomes.”

Itraconazole can be used to treat superficial infections of the skin and nails, as well as systemic fungal infections of the major organs and is regarded as one of the broadest spectrum antifungal drugs.

According to the Mayne Pharma, SUBA is a technology developed to enhance the bioavailability of poorly soluble drugs. SUBA uses a “solid dispersion” in a polymer to increase the absorbency of drugs in the gastrointestinal tract to enhance the bioavailability. Additionally, the technology can potentially reduce the intra/inter-patient variability and reduce side effects.

Because of its enhanced bioavailability, the newly approved antifungal has a more predictable clinical response and enables a reduction in active drug quantity to deliver the required therapeutic blood levels.

SUBA-itraconazole can be taken with or without food and can be coadministered with drugs that lower gastric acidity without causing any reduction in itraconazole bioavailability, which can increase patient convenience.

In clinical studies, the most common adverse reactions (incidence ≥1%) included nausea, rash, vomiting, edema, headache, diarrhea, fatigue, fever, pruritus, hypertension, abnormal hepatic function, abdominal pain, dizziness, hypokalemia, anorexia, malaise, decreased libido, somnolence, albuminuria, and impotence.

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

According to the company statement, the newly approved antifungal will launch in the United States in January 2019.