Adamas Pharmaceuticals, Inc. announced today that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 8,389,578 entitled "Composition and method for treatment of neurological disease." The claims of this invention are directed towards improved methods for treating Parkinson's disease using extended-release amantadine, and cover key features related to the dose strength and pharmacokinetic profile. Nurelin -a once-daily extended-release formulation of amantadine intended for nighttime administration - is being evaluated in a Phase 2/3 clinical study for the treatment of levodopa-induced dyskinesia (LID) in Parkinson's disease (PD) patients. The patent is set to expire in July, 2027.
"The issuance of the first patent for our Nurelin program is an important milestone in the development of this product, and further strengthens our overall portfolio of modified-release aminoadamantanes patents," said Gregory T. Went, Ph.D, Chief Executive Officer of Adamas and a co-inventor on the patent. "Adamas' patent portfolio now includes 14 issued U.S. patents, 22 patents granted by patent authorities outside of the U.S., and multiple pending applications covering our modified-release aminoadamantanes, used alone and in combination with other drugs. Each of these patents is derived from discoveries related to the tolerability of aminoadamantanes that led to the unique PK/PD profiles of our once-daily, higher dose and once-daily fixed-dose combination products."
To date, in addition to U.S. 8,389,578, Adamas has received numerous patents directed to composition of matter and methods of treatment, including:
-- Methods of treatment with products having certain pharmacokinetic profiles of extended release memantine (8,058,291; 8,173,708; 8,283,379; 8,362,085; 8,338,486);
-- Compositions of products having certain pharmacokinetic profiles of extended release memantine (8,168,209; 8,293,794; 8,327,792; 8,338,485);
-- Methods of reducing the titration of extended release memantine (7,619,007; 8,426,472); and
-- Compositions and methods of treating influenza with triple combination therapy (TCAD) (7,858,660; 7,981,930).