There is an important need for new, clinically differentiated treatment options for epilepsy, a chronic neurologic disorder characterized by recurrent unprovoked seizures. Epilepsy affects an estimated 2.2 million Americansi. Nearly two-thirds of epilepsy patients suffer from partial onset seizures, which affect one side of the brain. Despite advances, nearly one-third of epilepsy patients continue to suffer from seizures. ADS-4101 is designed as a once-daily, new high strength lacosamide to provide a clinically meaningful and differentiated treatment option for epilepsy patients with partial onset seizures.
"We are encouraged by the results of this Phase 1 clinical trial in ADS-4101 and look forward to advancing the program in 2017," said
About the ADS-4101 Clinical Development Program
The Phase 1 study of ADS-4101 was conducted in 24 healthy volunteers. The primary study objectives were to understand the pharmacokinetics and safety of a series of chrono-synchronous lacosamide capsule formulations and guide the selection of an ADS-4101 formulation for further clinical development. The trial compared the pharmacokinetic profile, safety, and tolerability of single-doses of four oral formulations of ADS-4101 with VIMPAT (lacosamide) tablets.
The timing of the ADS-4101 clinical development program and its potential approval is planned to allow Adamas to take advantage of ADS-4101's intellectual property protections and market opportunity.
About Adamas' Chrono-Synchronous Therapy Platform
Adamas has pioneered a development platform of chrono-synchronous therapies for chronic neurologic disorders focused on the synergy between time-dependent biologic processes responsible for disease activity and drug response. The Company is translating this understanding into a portfolio of products that potentially provide clinically meaningful benefits to patients with neurologic disorders by enabling higher doses with manageable tolerability.
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Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements contained in this press release regarding the potential future profile, clinical development, approval and success of ADS-4101 as a clinically differentiated treatment of partial onset seizures in epilepsy. Words such as "look forward," "on track," "expect," "potential," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to our research, clinical and development activities relating to ADS-5102 and ADS-4101, the regulatory and competitive environment and our business in general, see our Quarterly Report on Form 10-Q filed with the
Martin ForrestVice President, Corporate Communications & Investor Relations Adamas Pharmaceuticals, Inc.Phone: 510-450-3528 Email: firstname.lastname@example.org
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