Monday, July 14, 2008

Neurogen halts anti-insomnia drug trial

By Efrain Viscarolasaga

Drug developer Neurogen Corp., has suspended the clinical trials of its anti-insomnia drug adipiplon, citing a “higher than anticipated rate of unwanted next-day effects.”

Executives believe the unintended effects stem from the bilayer tabled formulation being used in the Phase 2/3 study. As a result, the company will suspend the dosing of the trial and investigate the tablet before proceeding with the trials, according to a company statement.

Branford, Conn.-based Neurogen (Nasdaq: NRGN) has executed two previous trials of adipiplon, both using immediate-release and controlled-release mechanisms. The current study is the first to use both forms laminated on a single tablet. In previous testing, which included over 600 subjects, adipiplon was “well tolerated,” according to a company statement.

Side effects included “significant grogginess and amnestic events” the morning following dosing, according to a conference call this morning. The review of the formulation could take two to three months to complete, said Neurogen president and CEO Stephen Davis on the conference call.

Davis called the suspension a “setback,” and said its was unclear whether or not there was a way to move forward using the current formulation, or if the company would move to redevelop the formula.

Neurogen makes drugs for the treatment of insomnia, anxiety, Parkinson’s disease and other conditions. In 2007 the company reported a net loss of $55.7 million on revenue of $15.4 million. In April, the company announced its plans to raise $30.6 million in a private placement and cut 45 workers to focus resources on clinical development.