1 November 2018 - - US-based specialty pharmaceutical company Eagle Pharmaceuticals, Inc.'s (NASDAQ: EGRX) fulvestrant formulation has not met the primary bioequivalence endpoints evaluating Eagle's formulation compared to Faslodex in its open label, randomized, pharmacokinetic and safety study conducted in 600 healthy female volunteers across multiple US sites, the company said.

The company will continue to evaluate the data, but as a result of this outcome, Eagle intends to focus on advancing the development of other products in its pipeline.

Eagle's fulvestrant product was intended to be administered at the recommended dose with one intramuscular injection instead of two high-viscosity intramuscular injections for Faslodex, and in less time. In addition, our low-viscosity formulation does not contain castor oil, and was intended for administration with a 23-gauge needle, which is 25% thinner than the current needle required to administer Faslodex.

Eagle is a specialty pharmaceutical company focused on developing and commercialising injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products.

Eagle's strategy is to utilise the FDA's 505(b) (2) regulatory pathway.