Neurogen says NG2-73 study shows insomnia drug safe, causes sleepiness

By E. Janene Geiss

Philadelphia, Dec. 8 - Neurogen Corp. said Thursday that it has completed a multiple ascending-dose study of its leading drug candidate for insomnia, NG2-73, and the compound was found to be safe and well-tolerated.

In the phase 1 trial of NG2-73, which selectively modulates receptors of the gamma-aminobutyric acid neurotransmitter system, study investigators said they also observed sleepiness among treated subjects, according to a company news release.

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 mg to 20 mg.

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, officials said.

NG2-73 was safe and well-tolerated in this trial and there were no serious adverse events, officials said, and subjective measures of sedation confirmed the hypnotic effects of NG2-73 at all doses studied.

"We're moving rapidly toward the initiation of our phase 2 transient insomnia trial with our immediate release tablet formulation. We've built the groundwork for getting into phase 2 quickly with solid results from our prior single ascending dose trial and this multiple ascending-dose study, William H. Koster, president and chief executive officer, said in the release.

Prescription drugs dominating the insomnia market work by modulating the GABA-A system of neurotransmitters, company officials said. GABA is a chemical naturally released in certain parts of the brain in order to inhibit brain activity.

The preclinical 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, officials said.

Neurogen is a Branford, Conn., drug development company focusing on small molecule drugs for insomnia, pain, depression, obesity and inflammation.

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