Printer Friendly

Eagle Pharmaceuticals Touts Results of Study for Fulvestrant.

M2 PHARMA-November 1, 2018-Eagle Pharmaceuticals Touts Results of Study for Fulvestrant


- 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.

((Comments on this story may be sent to

COPYRIGHT 2018 Normans Media Ltd.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2018 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:M2 Pharma
Article Type:Clinical report
Date:Nov 1, 2018
Previous Article:Janssen Touts Positive Long-Term Efficacy and Safety of Symtuza (D/C/F/TAF) in Treatment-NaA-ve Adults with HIV-1.
Next Article:FDA Grants Breakthrough Therapy Designation for UroGen Pharma's UGN-101 for the Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer.

Terms of use | Privacy policy | Copyright © 2020 Farlex, Inc. | Feedback | For webmasters