FDA asks for Ph III trial for Subazole approval

The US Food and Drug Administration has responded positively to the proposed development of Subazole, a half-dose formulation of itraconazole, and has requested that the developer, USA-based HalcyGen, undertake a Phase III study geared towards demonstrating the safety or improved safety of this formulation in comparison to the leading brand of the antifungal, Janssen Pharmaceutical's Sporanox.

HalcyGen's chief executive, Roger Aston, said: "the company is excited about following the FDA's clinical requirements for the forthcoming Phase III trial - safer is clearly better and would give us a substantial commercial advantage over Sporanox. If our half-dose form translated into a product that offered improved safety benefits to patients, we should achieve significant market penetration. The potential safety benefits that could be derived with a half-dose formulation would enhance our position in discussions with marketing partners." Subazole was licensed from Australia's Mayne Pharma, which is a wholly-owned unit of US health care firm Hospira.