Mayne Pharma is offering Tolsura (suba-itraconazole) in a 65-mg capsule, having received the Food and Drug Administration’s nod in Dec. 2018.
Tolsura is a new formulation of itraconazole indicated for the treatment of systemic fungal infections, including pulmonary and extrapulmonary blastomycosis; histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis; and aspergillosis, both pulmonary and extrapulmonary in patients who are intolerant of or who are refractory to amphotericin B therapy.
These serious infections most commonly occur in vulnerable or immunocompromised patients. For example, those with a history of cancer, transplants, HIV/AIDS or chronic rheumatic disorders, and are often associated with high mortality rates or long-term health issues.
“We are very pleased to launch Tolsura, a new formulation of itraconazole, incorporating Mayne Pharma’s proprietary suba-technology to improve the bioavailability of poorly soluble drugs. Tolsura provides a new treatment option for patients and physicians fighting these life-threatening fungal infections,” Mayne Pharma CEO Scott Richards said. “This launch has enabled Mayne Pharma to establish a new institutional sales team focused on hospital based infectious disease specialists. We look forward to bringing further specialty product innovations to market over the coming years with our pipeline of products under development.”