EMERYVILLE, Calif - Adamas Pharmaceuticals Inc. today announced in a press release that the United States Patent and Trademark Office (USPTO) issued US Patent No. 8,741,343 entitled "Method Of Administering Amantadine Prior To A Sleep Period." The claims of this patent are directed towards administration, prior to bedtime, of certain formulations of amantadine HCl, including Adamas' lead product ADS-5102 and similar amantadine-based products.
"This is the second issued US patent that covers our ADS-5102 program, adding additional protection for the timing of administration of controlled-release amantadine formulations," said Gregory T. Went, PhD., chief executive officer of Adamas and a co-inventor on the patent. "The nighttime administration of our proprietary amantadine formulation was evaluated in our Phase 2/3 study, which met its primary endpoint. We are continuing to pursue additional composition of matter and methods of treatment patents to protect controlled-release amantadine products."
ADS-5102 and related controlled-release amantadine products are currently covered by two issued US method of use patents that expire in 2027 and 2030 and an additional five US patent applications. These patents and patent applications are wholly owned by Adamas and are not subject to any license agreements. The company also owns additional foreign patent applications covering ADS-5102.
The company's strategy is to discover novel pharmacokinetic and pharmacodynamic relationships and to obtain patent protection for pharmacokinetic profiles, timing of administration, dose strengths and drug combinations. Secondarily, Adamas seeks to protect specific formulations. Overall, Adamas' patent portfolio of pharmacokinetic enhancement and fixed-dose combination inventions related to its CNS product portfolio now includes 15 issued US patents, 18 patents granted by patent authorities outside of the US, and multiple pending applications.
Adamas' most advanced wholly-owned product candidate is ADS-5102 (amantadine HCl), a high dose, controlled-release version of amantadine, that is administered once daily at bedtime. Adamas is initially developing ADS-5102 for the treatment of levodopa-induced dyskinesia, or LID in patients with Parkinson's disease. LID is a movement disorder that frequently occurs in patients after long-term treatment with levodopa, the most widely used drug for Parkinson's disease. There are no approved drugs for the treatment of LID in the United States or Europe. Adamas is also evaluating ADS-5102 as a potential treatment for chronic behavioral symptoms associated with traumatic brain injury, or TBI.
Adamas Pharmaceuticals, Inc. is a specialty pharmaceutical company driven to improve the lives of those affected by chronic disorders of the central nervous system. The company achieves this by modifying the pharmacokinetic profiles of approved drugs to create novel therapeutics for use alone or in fixed-dose combination products. Adamas is currently developing its lead wholly-owned product candidate, ADS-5102, for a complication of Parkinson's disease known as levodopa-induced dyskinesia, or LID, and as a potential treatment for chronic behavioral symptoms associated with traumatic brain injury, or TBI. The company's portfolio also includes a fixed-dose combination product candidate, MDX-8704, being developed with Forest Laboratories, Inc. and an approved controlled-release product Namenda XR ®, which Forest developed and is marketing in the United States under an exclusive license from Adamas. For more information, please visit www.adamaspharma.com.