For Immediate Release
Date: May 8, 2008
One of the First Advances for Life-Saving Treatment of Malignant Hyperthermia in 30 Years
Louisville, KY – US WorldMeds, a Kentucky-based specialty pharmaceutical company, today announced that it has completed development of and filed a provisional patent for Dantrolene Sodium for Injection that will dramatically enhance the medication’s reconstitution time to 20 seconds or less. Introduction of this fast reconstituted Dantrolene Sodium for Injection is expected to represent an advancement in the pharmacotherapy of patients experiencing malignant hyperthermia during surgery.
Dantrolene Sodium for Injection is already sold as a generic product by US WorldMeds, which has captured approximately 60% of the US market since the product’s launch on October 4, 2007. It is the only generic substitute for Dantrium® Intravenous. US WorldMeds’ improved reconstitution product is expected to meet all current FDA approved release specifications. US WorldMeds plans to file a submission in 2008 to obtain FDA approval of its Dantrolene Sodium for Injection with improved reconstitution.
Board-certified anesthesiologist Dr. Richard Morris commented: “This enhanced reconstitution time is an important improvement to intravenous dantrolene sodium and represents one of the first advances for this life-saving treatment in 30 years.”
Dantrolene Sodium for Injection is indicated, along with appropriate supportive measures, for the management of fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. It also is indicated preoperatively and sometimes postoperatively in individuals judged to be malignant hyperthermia susceptible.
Malignant hyperthermia is life threatening and requires immediate medical attention and treatment. It is a rare but potentially fatal reaction to the use of certain inhalation anesthetics, which causes a rapid rise in body temperature in susceptible individuals.
Intravenously administered dantrolene sodium is the only product indicated to treat malignant hyperthermia. With up to 36 vials of dantrolene sodium needed to treat one case of this condition, enhanced speed of reconstitution presents a distinct advantage to a physician faced with the task of administering enough product to reverse this time-sensitive reaction before permanent damage or death can occur.
Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with dantrolene sodium therapy. There have been reports of thrombophlebitis following administration of intravenous dantrolene. There have been rare reports of urticaria and erythema possibly associated with the administration of i.v. dantrolene sodium.
For additional information, including the full prescribing information for Dantrolene Sodium for Injection, please visit US WorldMeds website at www.usworldmeds.com.
Dantrium® is a registered trade name of JHP Pharmaceuticals.
We are a specialty pharmaceutical company, located in Louisville, Kentucky, whose mission is to develop, license and commercialize unique and significant pharmaceuticals that address unmet medical needs or overcome the limitations of existing products.