Catalyst Pharma Gets Breakthrough Therapy Designation For Firdapse

(RTTNews) - Catalyst Pharmaceutical Partners, Inc.'s (CPRX) investigational product Firdapse has received "Breakthrough Therapy Designation" by the U.S. Food and Drug Administration or FDA for the symptomatic treatment of patients with Lambert-Eaton Myasthenic Syndrome or LEMS. Firdapse is Catalyst's investigational therapy that is being evaluated to treat 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 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 in LEMS patients. Firdapse has the potential to provide significant relief of the often debilitating symptoms of the disease, including muscle weakness, difficulty swallowing and talking, drooping of eyelids and facial weakness.