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news.Neurogen Corporation has commenced a phase II clinical trial in chronic insomnia patients with the company's insomnia agent, NG2-73.
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The phase II clinical trial is designed to determine the efficacy and safety of five different dose and formulation profiles of NG2-73. The primary endpoint will be the time it takes to fall asleep. Sleep maintenance will be explored in several secondary endpoints.
NG2-73 selectively modulates receptors of the gamma-aminobutyric acid neurotransmitter system and is one of several un-partnered compounds in Neurogen’s portfolio.
The study will test doses and formulations of NG2-73 which are expected to span the therapeutic range. Doses to be tested include sustained release formulations.
“We are building on the positive and highly significant results of our phase II transient insomnia study, where NG2-73 demonstrated dramatic improvement over placebo for LPS,” said William Koster, president and CEO of Neurogen.
“In order to expand and intensify our knowledge of doses and formulations of NG2-73 for duration of action, we plan to launch an additional concurrent study in insomniacs later this year.”