Marinus Pharmaceuticals, Inc., the leader in development of neurosteroids for central nervous system disorders, announced that the United States Patent and Trademark Office (USPTO) issued the company Patent Number 7,858,609 entitled, “Solid ganaxolone formulations and methods for the making and use thereof.” The patent describes a novel class of small molecules to improve stability and bioavailability of nano-particulate formulations of ganaxolone and will provide coverage until the end of 2026.
Neurosteroids like ganaxolone have been difficult to formulate in the past because of differences in exposure that are dependent on the dose and amount of food in the stomach, commented Kenneth Shaw, PhD, senior vice president, R&D at Marinus. Marinus discovery of a novel class of stabilizing agents has produced new nano-particulate formulations of ganaxolone that appear to be superior to historical formulations in minimizing these differences.
The company has submitted a second patent application covering a new synthesis method for ganaxolone that decreases the number of process steps thus increasing cost efficiency.
Ganaxolone is a synthetic neurosteroid and a derivative of the naturally occurring neuro-modulator, allopregnanolone. Ganaxolone has been administered to more than 950 healthy adult volunteers and patients in phase I and phase II studies. Completed phase II epilepsy studies has generated data supportive of the efficacy and safety of ganaxolone in the treatment of both children and adults suffering from refractory epilepsy (patients who continue to have seizures despite taking multiple anticonvulsant drugs).
Scientific research has suggested that ganaxolone therapy may be useful in the treatment of several other central nervous system disorders including Post-Traumatic Stress Disorder (PTSD) and Fragile-X Syndrome (FXS). Ganaxolone is being developed as a first in class treatment in epilepsy, PTSD and FXS.
Marinus has successfully developed several proprietary and novel patented formulations of ganaxolone.
Marinus is a specialty pharmaceutical company dedicated to the reformulation, development, and commercialization of novel drugs to treat serious neurological and psychiatric disorders.