LCS Therapeutics, a privately-held pharmaceutical development company, has entered into a strategic collaboration with Lucerne Biosciences, LLC (Lucerne Biosciences) to commercialize US Patent No. 8,318,813 entitled "Method of Treating Binge Eating Disorder." Patent '813 features claims that encompass the use of the amphetamine prodrug lisdexamfetamine dimesylate (l-lysine-d-amphetamine) alone, or in combination with other pharmacologic therapies, for the treatment of Binge Eating Disorder (BED) according to its current diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
"This strategic collaboration with Lucerne Biosciences marks an important step forward in bringing much needed public attention to the diagnosis and treatment of BED. BED is a serious eating disorder currently without any FDA-approved medication treatments and for which, unfortunately, there have been many public misconceptions. Developing safe and effective treatments for eating disorders more generally, and for BED in particular, continues to be a critically important unmet need long-recognized in the medical community," said Louis Sanfilippo, M.D., CEO of LCS Therapeutics.
"Recent studies show that between 2 to 3% of the US population will suffer from BED at some point in their lifetime and many of these patients will have a chronic course of symptoms with significant burdens to their emotional and physical health," said Dr. Sanfilippo, who also is a voluntary faculty member at Yale University School of Medicine and teaches psychopharmacology to psychiatry residents.
Lisdexamfetamine dimesylate (l-lysine-d-amphetamine) is an amphetamine prodrug approved in the United States for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). Lisdexamfetamine dimesylate is not approved by the Food and Drug Administration (FDA) for the treatment of BED. Based on the Prescription Drug User Fee Act (PDUFA) and the FDA's recent priority review acceptance of a supplemental New Drug Application (sNDA) for the use of lisdexamfetamine dimesylate in the treatment of BED in adults, the FDA is expected to make a decision for this novel use of the drug in February 2015. The use of any prescription medication including lisdexamfetamine dimesylate, alone or in combination with other medications, should be done under close medical supervision.
LCS Therapeutics is a privately-held pharmaceutical development company founded to provide safer, more effective drug treatments for patients suffering from psychiatric disorders by discovering novel uses and reformulations of clinically validated drugs.
BED is a recognized eating disorder in the DSM-V characterized by eating unusually large amounts of food in a discrete period of time (i.e., within a 2 hour period) and a sense of lack of control over eating during the episode. Binge eating episodes in BED are also associated with at least three (or more) of the following: eating much more rapidly than normal; eating until feeling uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed or very guilty after overeating.