FDA approves IND for HalcyGen's SUBA-Itraconazole

Australia's HalcyGen Pharmaceuticals has received approval from the US Food and Drug Administration to begin pivotal pharmacokinetic studies for SUBA-Itraconazole, its novel formulation of the $600.0 million-a year antifungal.

The allowance to proceed comes 30 days after HalcyGen submitted its Investigational New Drug application and, according to the firm, is a major milestone in the registration strategy for SUBA-Itraconazole which will examine the bioequivalence of the agent and the market-leading product, Johnson & Johnson's Sporanox (itraconazole).

HalcyGen has clinically evaluated its patented formulation in five successful pharmacokinetic studies in Australia. These assessments have demonstrated that the product has significantly-improved bioavailability (absorption by the gastrointestinal track) compared with the market leader, enabling the use of a lower dose. HalcyGen noted that its formulation also provides for more stable blood levels compared to Sporanox.