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news.Texan pharmaceuticals firm Fabre-Kramer said it has achieved positive results in its phase III program focusing on Gepirone ER in the treatment of major depression.
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The program consisted of two randomized, placebo-controlled clinical studies that were carried out in moderately depressed patients.
One study, which was conducted in 248 depressed patients, demonstrated that patients treated with Gepirone ER showed reduced symptoms of depression compared with placebo.
The second study was conducted in 206 depressed patients and also showed improvement in depressive symptoms, but failed to reach statistical significance at endpoint.
The majority of adverse events as a result of the Gepirone ER treatment were lightheadedness and nausea, which the company claims are common antidepressant side effects. Other common side effects such as sexual dysfunction were not seen in Gepirone ER treated patients in either study.
Fabre-Kramer said these latest results support earlier positive studies conducted on the drug for major depression and will now enable the firm to submit an improved set of data to the FDA for review.
The company is also planning to submit an amended NDA to the FDA later this year. Eventually it hopes to market Gepirone ER in the $20bn global antidepressant industry.
“Working by a new mechanism of action, Gepirone ER, if approved, could provide a new treatment modality for depressed patients who are not helped by currently available treatments,” noted Stephen Kramer, CEO of Fabre-Kramer.