Eagle Pharmaceuticals Announces Fulvestrant Study Results

Eagle Pharmaceuticals (Nasdaq: EGRX) announced that the Company’s fulvestrant formulation has not met the primary bioequivalence endpoints evaluating Eagle’s formulation compared to FASLODEX in its open label, randomized, pharmacokinetic (PK) and safety study conducted in 600 healthy female volunteers across multiple U.S. sites.

As quoted in the press release:

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.

“At this time, and given the results of the fulvestrant trial, we plan to focus on other promising programs in our pipeline, including exertional heat stroke, a potential nerve agent indication and intramuscular formulation for RYANODEX, and our pemetrexed and vasopressin assets,” stated Scott Tarriff, Chief Executive Officer.

Click here to read the full press release.