Labopharm Inc has received a complete response letter from the US Food and Drug Administration (FDA) for the new drug application (NDA) submission of its novel formulation of the antidepressant trazodone.
The letter indicates Labopharm's application cannot be approved in its present form due to deficiencies following an FDA inspection of the active pharmaceutical ingredient (API) manufacturing facility, which was completed July 3, 2009. 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 API manufacturer, Angelini, has informed Labopharm that, further to the FDA's complete response letter to Labopharm, in which the FDA raises observations concerning the Drug Master File (DMF) holder in the section 'Facility Inspections', Angelini can confirm that the observations raised by the FDA are not critical and that it has not been questioned about the continued supply of trazodone hydrochloride to the US market. Angelini intends to address the observations raised by the FDA in an action plan that Angelini is going to submit to the FDA by July 24, 2009.
"We intend to work closely with the FDA and Angelini to resolve these issues as rapidly as possible," said James R Howard-Tripp, president and chief executive officer, Labopharm Inc. "We continue to prepare for the commercialization of our novel antidepressant and intend to launch in the US market as soon as possible after we receive approval."
The company will provide further information regarding the timing of its response to the FDA when available.
Labopharm submitted the NDA for its novel formulation of trazodone in September 2008. The NDA is based on data from five pivotal pharmacokinetic studies and the positive results from its North American phase-III placebo-controlled clinical trial (study 04ACL3-001), which enrolled more than 400 patients. The results of this study are found in the May 2009 issue of Psychiatry (Edgemont) (Volume 6, Number 5).
Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies.