A once-daily form of trazodone, a second-generation antidepressant that has been available for the treatment of depression for decades, has been rejected by the U.S. Food and Drug Administration (FDA) today.
Labopharm, the Montreal-based maker of the novel form of trazodone, said the FDA denial letter cited deficiencies at its manufacturing facility for the new form of the drug.
Trazodone is an antidepressant known for having beneficial therapeutic effects felt within a few weeks, while the more popularly-prescribed, third-generation selective serotonin reuptake inhibitor (SSRI) antidepressants can take months.
Because trazodone’s half-life is only 3 to 6 hours, it must be taken more than once a day. A once-a-day formulation would make the antidepressant more easy to take and make it more compatible with other modern antidepressant prescriptions.
The FDA letter states: “Satisfactory resolution of these deficiencies is required before this application may be approved.” No efficacy or safety issues were raised.
The active ingredient contained in the treatment is manufactured by a contract drug manufacturer called Angelini.
“We intend to work closely with the FDA and Angelini to resolve these issues as rapidly as possible,” James Howard-Tripp, president and chief executive at Labopharm, said in a news release.
“We continue to prepare for the commercialization of our novel antidepressant and intend to launch in the U.S. market as soon as possible after we receive approval.”
Earlier this year, the company said it hoped to launch the product in the United States by the end of 2009 or early 2010.
Antidepressants had sales of $12 billion in the United States in 2007. Trazodone is also prescribed at lower doses as a sleep aid.