Rapastinel (GLYX-13) Shown to Improve Ketamine or PCP-Induced Cognitive Impairment in Mice

DUBLIN, Jan. 19, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced today that new data on the investigational medication rapastinel (GLYX-13) and its lack of impairment on cognitive function were published in the peer-reviewed journal Behavioural Brain Research.

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"This work demonstrates that rapastinel, unlike ketamine, did not induce transient or persistent cognitive deficits in normal mice. Further, rapastinel, but not ketamine, as administered here, demonstrated pro-cognitive benefits in a well-studied animal model of cognitive impairment. This difference merits further study in patients who are candidates for rapidly acting antidepressant treatment" said Herbert Y. Meltzer, MD, Professor of Psychiatry, Northwestern Feinberg School of Medicine.

The goal of this study was to compare the effects on cognition of rapastinel and ketamine in novel object recognition (NOR) in mice. The NOR task is a validated animal model of human declarative memory (memory of facts and events) that has been widely used to identify differences across compounds. Deficits in learning and memory are often comorbid conditions in patients suffering from a number of mental illnesses including major depressive disorder, bipolar disorder, and schizophrenia.

"Allergan is committed to advancing potential new treatment options for mental health. We are encouraged by these promising study findings and what they could mean in clinical practice and plan to begin pivotal phase 3 trials of rapastinel later this year" said David Nicholson, Executive Vice President and President of Global R&D brands at Allergan.  

The study found that unlike ketamine and phencyclidine (PCP), rapastinel (a functional NMDA receptor modulator) did not cause deficits in NOR in mice. This study also demonstrated rapastinel's ability to reverse NOR deficits produced by a single exposure to ketamine or multiple doses of PCP or ketamine. In addition, rapastinel like ketamine has fast onset antidepressant effects. The data from this study demonstrates that rapastinel does not share some of the less desirable pharmacological properties of ketamine.

About rapastinel (GLYX-13) and NRX-1074 (AGN-241660)

Rapastinel (formerly known as GLYX-13) is an investigational intravenous formulation of a novel NMDA receptor partial agonist, which is being evaluated for adjunctive treatment of MDD, and has shown a rapid onset of antidepressant efficacy 1 day after a single dose in a Phase 2 clinical trial of patients with MDD who had an inadequate response to one or more antidepressants. No psychotomimetic or hallucinogenic side effects were observed with rapastinel. A series of Phase 3 registration trials are planned to begin in 2016.

NRX-1074 is an investigational orally available derivative of rapastinel that is entering Phase 2 as a monotherapy treatment for adults with MDD. An intravenous formulation of NRX-1074 has previously shown a rapid antidepressant efficacy in an initial single-dose Phase 2 study in patients with MDD. Proof of concept studies of NRX-1074 are planned for 2016.

About Major Depressive Disorder (MDD)

Approximately 16 million Americans are living with Major Depressive Disorder (MDD). There remains a significant unmet need in treating MDD. Upwards of 70% of patients with (MDD) are partial or non-responders to first-line therapies which include SSRIs and SNRIs. Additionally, the STAR*D trial reported that only 33% of patients reported remission of their MDD symptoms after monotherapy with an SSRI. In patients that do respond to an SSRI, numerous clinical trials have shown that it can take anywhere from 2 to 6 weeks for a patient perceive and report that their depressive symptoms are improving. During these first 2 to 6 weeks of traditional monoamine-based therapy, patients may continue to experience significant depressive symptoms, which can include suicidal ideation in patients with severe, recurrent, or chronic depression.

About Allergan

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

For more information, visit Allergan's website at www.allergan.com.

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 (such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

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