NEW HAVEN, Conn., April 7, 2011 /PRNewswire/ — Marinus
Pharmaceuticals, Inc., the leader in development of neurosteroids
for central nervous system disorders, today 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 nanoparticulate 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, Ph.D., Senior Vice President, R&D at
Marinus. “Marinus’ discovery of a novel class of
stabilizing agents has produced new nanoparticulate 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 neuromodulator, allopregnanolone.
Ganaxolone has been administered to more than 950 healthy
adult volunteers and patients in Phase 1 and Phase 2 studies.
Completed Phase II epilepsy studies have 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 posttraumatic stress
disorder (PTSD) and Fragile-X syndrom