FDA Approval Good News For Ashland Based Lyotropic Therapeutics
Thursday, July 24, 2014
Eagle Pharmaceuticals ($EGRX), Woodcliff Lake, NJ, this week announced it received FDA approval for its new-and-improved formulation of dantrolene sodium, which will be sold as Ryanodex, for potentially lethal cases of malignant hyperthermia.
This is good news for Lyotropic Therapeutics, Ashland, Virginia, a long time member of Virginia Bio. Eagle Pharmaceuticals is the exclusive licensee under a license with Lyotropic Therapeutics to a family of patents and applications that relate to low volume formulations of dantrolene and methods of treatment using dantrolene that cover the approved product.
Malignant hyperthermia (MH) is an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals. Ryanodex was granted priority review status by the FDA in March 2014, a regulatory review process that expedites the review of drugs that treat life threatening and serious conditions and provide a significant improvement in safety or effectiveness over the existing therapies. FDA had designated Ryanodex as an Orphan Drug in August 2013.
Ryanodex is the first significant enhancement to MH treatment options in more than three decades, reformulated to improve performance in managing MH. The product has the potential to become a new standard of care for the treatment of malignant hyperthermia, because it enables anesthesiologists to deliver a therapeutic dose of the only antidote for MH (dantrolene sodium) in a much more expedient manner than currently possible with existing formulations of IV dantrolene sodium, potentially saving lives and reducing MH-related morbidity. Ryanodex can be prepared and administered in less than one minute by a single healthcare practitioner.
Eagle Pharmaceutical’s press release can be found here.