Date: 2016-01-19
Type of information: Publication of results in a medical journal
phase: preclinical
Announcement: publication of results in Behavioural Brain Research
Company: Allergan (Ireland)
Product: rapastinel (GLYX-13)
Action
mechanism: NMDA receptor agonist. 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.
Disease: major depressive disorder (MDD)
Therapeutic area: Mental diseases - CNS diseases
Country:
Trial details:
Latest
news: * On January 19, 2016, Allergan announced 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 . 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. The study found that unlike ketamine and phencyclidine (PCP), rapastinel 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.
