CORAL GABLES, Fla. (GLOBE NEWSWIRE) — Catalyst Pharmaceutical Partners, Inc., a specialty pharmaceutical company focused on the development and commercialization of novel prescription drugs targeting rare neuromuscular and neurological diseases, today announced that its investigational product Firdapse™ (amifampridine phosphate) has received "Breakthrough Therapy Designation" by the U.S. Food and Drug Administration (FDA) for the symptomatic treatment of patients with Lambert-Eaton Myasthenic Syndrome (LEMS). Firdapse™ is Catalyst's investigational therapy that is being evaluated for the treatment of the debilitating symptoms associated with LEMS, including muscle weakness.
"We are very pleased to have received Breakthrough Therapy Designation for Firdapse™ and we are excited by the FDA's decision to place our product in a category that may enable expedited development and review for patients with LEMS," said Patrick McEnany, President and Chief Executive Officer of Catalyst. "With no approved or effective symptomatic treatment currently available for LEMS, Firdapse™ has the potential to be the first-line treatment option for patients with this rare condition."
Breakthrough Therapy Designation for Firdapse™ was based on clinical data from several previously published clinical trials of amifampridine (3,4-DAP) in patients with LEMS. Firdapse™ has the potential to provide significant relief of the often debilitating symptoms of the disease, including muscle weakness (e.g. difficulty walking), difficulty swallowing and talking, drooping of eyelids and facial weakness.