Neurogen Corporation (NASDAQ:NRGN)
Industry: Healthcare

OFF LIST - 1864 consecutive market days: OFF LIST as of 01/08/2009 Through 11/14/2016

Neurogen Corporation, incorporated in 1987, is a drug discovery and development company focusing on new small molecule drugs to improve the lives of patients suffering from disorders with significant unmet medical needs, including neurological diseases, pain, metabolic diseases and inflammation. Neurogen has generated a portfolio of new drug programs through its fully integrated drug discovery and development processes. Small molecule drugs typically are suitable for oral administration as a pill, while large molecule drugs typically are administered by injection. Neurogen conducts its research and development independently and, when advantageous, collaborates with pharmaceutical companies during the drug research and development process to obtain additional resources and to access complementary expertise. As of December 31, 2005, the Company had a collaboration with Merck Sharp & Dohme Limited (Merck), a subsidiary of Merck & Co., Inc. Insomnia Program Neurogen is developing drugs to treat sleep disorders, primarily insomnia, which selectively modulate certain receptor subtypes of the gamma-aminobutyric acid (GABA) neurotransmitter system, an area in which Neurogen has worked since its founding. Its approach is to identify drug candidates that have a different GABA receptor subtype binding profile than marketed drugs. Animal studies suggest that compounds with the appropriate receptor subtype selectivity could provide a wider separation than existing GABA-based drugs between the dose levels that induce sleep and the levels at which undesirable side effects are observed. Drugs to treat insomnia should not only induce sleep but they should have desirable pharmacokinetic properties, allowing the drug to work quickly and then be mostly eliminated from the body before waking in the morning. The mechanism of the Company's lead insomnia compound, NG2-73, may offer the opportunity for an improved side effect profile compared to marketed insomnia medications, as well as those in active development. Preclinical animal studies suggest that the specific GABA receptor profile of NG2-73 may provide the benefit of sleep with a reduction in side effects associated with the first generation GABA hypnotic agents. Neurogen announced on September 22, 2005, that it had completed the first-in-human, single ascending dose study with NG2-73. In this Phase I trial, the compound was safe and well tolerated across a broad dose range. Consistent with the expected action of the drug, study investigators also observed sleepiness among treated subjects. On December 8, 2005, Neurogen announced that it had completed a multiple ascending dose study with NG2-73. In this Phase I trial, the compound was safe and well tolerated. Consistent with the expected action of the drug in the single ascending dose study, investigators also observed sleepiness among treated subjects. Neurogen announced on December 14, 2005, that it had commenced Phase II human testing with NG2-73. The primary endpoint of the study will measure the efficacy of NG2-73 in reducing time to onset of persistent sleep in a model of transient insomnia in healthy adults. This Phase II clinical trial is a randomized, double-blind, placebo-controlled study, designed to determine the efficacy of four dose levels of NG2-73 compared to placebo in reducing the time it takes to fall to sleep as defined by Latency to Persistent Sleep (LPS). LPS will be measured in a single-night model of transient insomnia where temporary insomnia is induced in normal subjects by environmental stress. Similar transient insomnia studies have been performed in the clinical development of other sleep agents. The exposure response relationship for NG2-73 will be examined using pharmacokinetic/pharmacodynamic modeling and a routine safety assessment will be made. Neurogen plans to conduct the study at 12 sites in the United States and plans to enroll healthy adult subjects in five treatment groups totaling 360 subjects. Pain Management Program In January 2004, Neurogen established a collaborat

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