Adamas Pharmaceuticals, Inc., a leading developer of aminoadamantane-based therapeutics, has received key patent from the United States Patent and Trademark Office (USPTO). The US 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 night time administration - is being evaluated in a phase II/ III 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 programme 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, PhD, chief executive officer of Adamas and a co-inventor on the patent. "Adamas' patent portfolio now includes 14 issued US patents, 22 patents granted by patent authorities outside of the US, 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 US 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).
Nurelin (ADS-5102) is a proprietary formulation of amantadine in development for the treatment of central nervous system (CNS) disorders, including LID in PD patients. Nurelin's pharmacokinetic profile is designed to reduce CNS side effects associated with immediate-release forms of amantadine, while offering potential for enhanced efficacy. The novel chronotherapeutic pharmacokinetic profile of Nurelin is characterized by: up to 2.7 times higher plasma concentrations during the daytime hours when the motor and non-motor symptoms of Parkinson's disease are at their peak; lower plasma concentrations overnight, which may reduce sleep disturbance and vivid dreams occasionally associated with amantadine; and a reduced initial rate of rise in plasma concentration, which is expected to improve overall CNS tolerability relative to immediate-release amantadine.
The efficacy and tolerability of multiple doses of Nurelin in the treatment of LID in Parkinson's disease patients is currently being studied in a phase II/ III study. This study, known as EASED (Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia), is designed to evaluate the efficacy of three dose strengths of Nurelin for the treatment of LID, and to confirm tolerability and dosing.