Zosano complete end-of-Ph II ZP-PTH meeting with FDA

15 December 2008

Texas, USA-based Zosano Pharma, a privately-held firm developing products using a novel transdermal delivery technology, says that it has completed an end-of-Phase II meeting with the Food and Drug Administration regarding its ZP-PTH rapid delivery patch for the treatment of osteoporosis in women at high risk of fracture.

The meeting was an opportunity for Zosano to review with the FDA requirements for the eventual New Drug Application filing of ZP-PTH; specifically a Phase III pivotal non-inferiority study to compare lumbar spine bone mineral density at 12-months with ZP-PTH patch to Forteo (teriparatide) injection. Zosano reached agreement with the agency on all key elements of the clinical trial, including the use of BMD as an appropriate surrogate endpoint to bridge to established fracture efficacy data for Forteo.

Zosano also received confirmation from the FDA that a 505(b)(2) regulatory filing is appropriate for the ZP-PTH patch.

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