Green light at Angelini plant resurrects antidepressant prospects
pharmafile | October 13, 2009 | News story | Manufacturing and Production |Â Â AngeliniÂ
Canadian drugmaker Labopharm has been boosted by the news that manufacturing problems holding up approval of its novel antidepressant product, a sustained release formulation of trazodone, have been resolved.
Trazodone was originally developed by Italian company Angelini, and in 2004 Labopharm signed an agreement with the firm to develop a once-daily version of the drug.
The sustained-release formulation was submitted for approval with the US Food and Drug Administration in September 2008 but in July this year Labopharm’s marketing application was turned down by the agency on the grounds that there were deficiencies at Angelini’s manufacturing facility.
In the latest development, Angelini ‘s production plant has been given the all-clear by the FDA, opening the path to product approval.
Immediate-release formulations of trazodone have been used for the treatment of patients with depression and anxiety for years, but as it has a half-life of just three to six hours it requires multiple doses a day to be effective.
As a result it fell out of favour in the late 1980s and 1990s when newer, once-daily antidepressants, particularly selective serotonin reuptake inhibitors such as Eli Lilly’s Prozac (fluoxetine), came onto the market.
Labopharm is convinced it has a winner on its hands with the new formulation because trazodone can start to have a beneficial effect on depressive symptoms within a few weeks, while the benefits of SSRIs can take months to kick in. Its mechanism of action – serotonin antagonist reuptake inhibition – could also help it avoid some of the side effects seen with SSRI’s such as weight gain and sexual dysfunction.
“Angelini … has received a letter from the FDA stating that [it] has appropriately addressed all deficiencies cited by the FDA following its inspection of the manufacturing facility in June and July of this year,” the Canadian firm said in a statement.
“The letter further states that Angelini’s manufacturing facility has been classified as acceptable.”
The FDA’s rejection of Labopharm’s formulation did not raise any safety or efficacy issues with the product outside of the manufacturing concerns, so the drugmaker is hopeful its application is back on track.
The agency is scheduled to deliver a verdict on the marketing application by February 11, 2010.
