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Eagle Pharmaceuticals announced a clinical development plan to support the submission of a New Drug Application for the company's fulvestrant formulation. Fulvestrant, an estrogen receptor antagonist with no agonist properties, is approved by the FDA for the treatment of advanced hormone-related breast cancers. In March and June, Eagle met with the FDA and mutually agreed to a clinical program that could provide an efficient approval pathway for the company's fulvestrant formulation. The main goal of the clinical research program is to determine if the unique properties of Eagle's fulvestrant formulation will result in greater inhibition of estrogen receptors, potentially leading to improved efficacy outcomes, including lower disease progression rates, compared to current treatment options. Once the pilot study results are reviewed, a clinical pivotal trial designed to evaluate fulvestrant exposure and estrogen receptor inhibition based upon the parameters determined with the FDA will be conducted in a target patient population. Eagle believes the pivotal study could be completed within approximately 12 months of commencing enrollment.

Eagle Pharmaceuticals announced positive results of its study to evaluate the neuroprotective effects of RYANODEX, or dantrolene sodium, secondary to nerve agent exposure, conducted with the U.S. Army Medical Research Institute of Chemical Defense, or USAMRICD. The study results show a p-value of 0.04 or less compared to the control group in six critical areas of the brain. We believe these results demonstrate the neuroprotective effects of RYANODEX. It has been hypothesized that nerve agent poisoning triggers intracellular calcium release in the body. The study data supports the proposed mechanism of action of RYANODEX, which modulates intracellular calcium in different organs including the brain. "We intend to meet with the FDA to discuss next steps as soon as possible. Given the life-threatening nature of NA exposure, we believe this indication would be evaluated under the FDA's Animal Rule. If approved, this would be an additional indication for RYANODEX, as we continue to develop additional potential indications and an intramuscular formulation of the drug," said the company.