WellSpring Pharmaceutical Corporation has licensed the United States rights to the trademark, scientific data, technology, and know how for Dibenzyline (phenoxybenzamine hydrochloride) injection from GlaxoSmithKline.
Dibenzyline injection was being supplied by GlaxoSmithKline under a compassionate use program only and has not been approved by the Food and Drug Administration. The financial terms of the deal were not disclosed.
Dibenzyline is a long acting alpha receptor blocking agent used to control the hypertensive crises associated with pheochromocytoma, a tumor of the adrenal gland. The treatment of choice for pheochromocytoma is surgery to remove the offending neoplasm. Use of Dibenzyline before, during and following surgical removal of the tumor provides the surgeon with better blood pressure control and related complications associated with the procedure.
Dibenzyline injectable is being studied by some physicians for several cardiovascular indications including adjunctive use during surgical correction of cardiac anomalies in children with Hypoplastic Left Heart Syndrome (a group of cardiac birth defects characterized by a small or absent left ventricle and marked narrowing of the ascending aorta, the major arterial vessel exiting the heart and supplying blood to the rest of the body). It has been reported that use of the drug improved the delivery of oxygen to the body. One of the surgical procedures used most often for correction of this birth defect is the Norwood Procedure. There are less than 1000 Norwood Procedures performed in the US annually.