Neurogen Announces Results of Phase I Multiple Ascending Dose Trial for Insomnia Drug
Thursday December 8, 7:30 am ET
BRANFORD, Conn., Dec. 8 /PRNewswire-FirstCall/ -- Neurogen Corporation (Nasdaq: NRGN - News) today announced that it has completed a multiple ascending dose study of the Company's leading drug candidate for insomnia, NG2-73, which selectively modulates receptors of the gamma-aminobutyric acid (GABA) neurotransmitter system. In this Phase I trial, the compound was safe and well-tolerated. Consistent with the expected action of the drug, study investigators also observed sleepiness among treated subjects.
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The study objectives were to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of NG2-73 given over a period of five days to healthy male and female subjects. The study was a randomized, double-blind, placebo-controlled evaluation, which included 32 subjects in four cohorts. Subjects received doses ranging from 5 milligrams to 20 milligrams. The linear, dose-related pharmacokinetics of NG2-73 established in an earlier single ascending dose study were confirmed and there was no accumulation of NG2-73 in study subjects over the five days of administration. NG2-73 was safe and well-tolerated in this trial and there were no serious adverse events. Subjective measures of sedation confirmed the hypnotic effects of NG2-73 at all doses studied.
William H. Koster, President and CEO, said, "We're moving rapidly toward the initiation of our Phase II transient insomnia trial with our immediate release tablet formulation. We've built the groundwork for getting into Phase II quickly with solid results from our prior single ascending dose trial and this multiple ascending dose study. We're also completing a Phase I pharmacokinetic/pharmacodynamic (PK/PD) study, where we are measuring multiple sleep parameters to correlate blood levels of drug with the degree of sedation. Information from the PK/PD study will be useful in establishing doses to explore in Phase II.
"We're evaluating several formulations of NG2-73, comparing different technologies with the intent to develop a drug that meets the needs of patients for both fast onset of sleep and sleep maintenance. We believe NG2-73 offers the opportunity for a compelling sleep agent in a growing market having unsatisfied medical need."
Neurogen announced first-in-human (FIH), single ascending dose study results for NG2-73 on September 22, 2005. In that Phase I trial, the compound was safe and well-tolerated across a broad dose range. The dose limiting effect of the drug in the FIH study was a deep sleep.
About Neurogen's Insomnia Program
Prescription drugs dominating the insomnia market work by modulating the GABA-A system of neurotransmitters. GABA is a chemical naturally released in certain parts of the brain in order to inhibit brain activity. Preclinical studies suggest that NG2-73 is pharmacologically distinct from currently marketed insomnia agents, as well as those in development. These studies with NG2-73 compared to the other GABA hypnotic agents that are potent agonists at multiple receptor subtypes, indicate that NG2-73 may provide the benefit of sleep with a reduction in next day side effects.
About Neurogen
Neurogen Corporation is a drug discovery and development company focusing on small molecule drugs to improve the lives of patients suffering from disorders with significant unmet medical need, including insomnia, pain, depression, obesity, and inflammation. Neurogen has generated a portfolio of compelling new drug candidates through its Accelerated Intelligent Drug Discovery (AIDD(TM)) system, its expertise in cellular functional assays, and its depth in medicinal chemistry. Neurogen conducts its research and development independently and, when advantageous, collaborates with world- class pharmaceutical companies. |
