EMERYVILLE, Calif., April 14, 2016 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that Rajesh Pahwa, M.D., Laverne & Joyce Rider Professor of Neurology, Director of the Parkinson’s Disease and Movement Disorder Center at the University of Kansas Medical Center, will present emerging science abstract # 014, “ADS-5102 (amantadine HCl) Extended-Release Capsules Reduced Levodopa-Induced Dyskinesia in the Phase 3 EASE LID Study,” on Tuesday, April 19, from 5:45 p.m. to 7:15 p.m. PT at the 68th American Academy of Neurology Annual Meeting, being held April 15 to April 21, 2016, in Vancouver, British Columbia.
Dr. Pahwa’s presentation is one of 14 abstracts selected for inclusion in the Emerging Science Session. These abstracts will be featured in 3-minute data blitz format during the first 45 minutes of the session from 5:45 p.m. to 6:30 p.m., followed by poster presentations from 6:30 p.m. to 7:15 p.m. Dr. Pahwa’s presentation will begin at 6:24 p.m. Emerging science abstracts are those which had key aspects of research conducted after the initial October 2015 AAN abstract submission deadline and deemed by the AAN Scientific Committee to be new and have sufficient scientific importance to warrant expedited presentation and publication.
To view the 2016 Emerging Science abstracts, please visit the AAN annual meeting website located at https://www.aan.com/conferences/2016-annual-meeting/abstracts/.
About ADS-5102
Adamas’ most advanced wholly owned product candidate is ADS-5102 (amantadine HCl), an extended-release version of amantadine that is intended for once daily administration at bedtime. ADS-5102 is designed to improve upon the pharmacokinetic (PK) profile of immediate-release amantadine, with the aim of enhancing efficacy without compromising the known tolerability profile. In PK studies, ADS-5102 has been shown to achieve high plasma amantadine concentrations in the early morning that are sustained throughout the afternoon and are lower in the evening.
Parkinson's Disease and Levodopa-induced Dyskinesia
Parkinson's disease is a chronic, progressive motor disorder that causes a variety of symptoms, such as tremors, rigidity, slowed movements and postural instability. The most commonly prescribed treatments for Parkinson's disease are levodopa-based therapies. In the body, levodopa is converted to dopamine to replace the dopamine loss caused by the disease. Patients initially receive relief from symptoms of Parkinson's disease for much of the day. This period of relief is known as ON time. As the effects of levodopa wear off, the symptoms of Parkinson's disease return. This is known as OFF time.
As Parkinson's disease progresses, most patients require increasing doses of levodopa to achieve equivalent therapeutic benefit. Patients may also experience symptoms of their disease upon waking, prior to the first dose of levodopa taking effect. Over time many patients will suffer from levodopa-induced dyskinesia (LID), a condition characterized by involuntary movements without purpose. As Parkinson's disease advances, the symptoms of LID often worsen in frequency and severity. Eventually the total time that a patient spends ON with LID can become a significant portion of his or her day.
ADS-5102 Phase 3 Program Overview
Adamas’ Phase 3 clinical program of ADS-5102 for the treatment of levodopa-induced dyskinesia (LID) is comprised of three placebo controlled-trials: EASED, EASE LID and EASE LID 3. EASED and EASE LID, which are both complete, enrolled 209 patients, of which 84 patients received a 340 mg dose of ADS-5102 once daily before bedtime for a prespecified period of time. In both trials, a statistically significant reduction in LID was achieved at each trial’s predefined period versus placebo as assessed by the UDysRS; week 8 (EASED) and week 12 and week 24 (EASE LID). The adverse events associated with ADS-5102 in the two completed trials were consistent with the known safety profile of amantadine. EASE LID 3 is ongoing and fully enrolled with 77 patients. Additionally, Adamas is continuing to conduct EASE LID 2, an open-label safety study, which is open to patients from EASED, EASE LID, EASE LID 3 and LID patients who have undergone deep brain stimulation. The company expects to submit a new drug application in 2016 and, pending a positive review, initiate commercial launch in 2017 with its own targeted sales force.
About Adamas Pharmaceuticals
Adamas Pharmaceuticals, Inc. is driven to improve the lives of those affected by chronic disorders of the central nervous system. The company seeks to achieve this by modifying the pharmacokinetic profiles of approved drugs to create novel therapeutics for use alone and in fixed-dose combination products. Adamas is currently developing ADS-5102, its lead wholly owned product candidate, for the treatment of levodopa-induced dyskinesia associated with Parkinson's disease and for the treatment of major symptoms associated with multiple sclerosis in patients with walking impairment. The company is also evaluating ADS-4101, an extended-release version of a FDA-approved single-agent compound for the treatment of epilepsy. The company's portfolio includes Namzaric™ and Namenda XR®, two approved products with Forest Laboratories Holdings Limited, an indirect wholly owned subsidiary of Allergan plc. Forest is responsible for marketing both products in the United States under an exclusive license from Adamas. For more information, please visit www.adamaspharma.com.
Namzaric™ is a trademark of Merz Pharma GmbH & Co. KGaA.
Namenda XR® is a registered trademark of Merz Pharma GmbH & Co. KGaA.
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 such as expectations regarding the submission of a New Drug Application, building a targeted commercial infrastructure, regulatory and commercial progress, and potential for ADS-5102 in levodopa-induced dyskinesia. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “may,” ”will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to the FDA’s interpretation and review of the ADS-5102 data and program, ongoing research, clinical and development activities of ADS-5102, the regulatory and competitive environment, as well as risks relating to Adamas’ business in general, see Adamas’ 10-K filed with the Securities and Exchange Commission on February 23, 2016. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes no obligation to update any forward-looking statement in this press release.