Labopharm upbeat about depression drug after FDA OKs API maker

By Gareth Macdonald

- Last updated on GMT

Related tags Antidepressant Selective serotonin reuptake inhibitor

Canadian drugmaker Labopharm says its Italian API maker Gruppo Angelini has resolved all the US FDA concerns about processes used to make a once-a day version of the depression drug trazodone.

In a statement issued yesterday, Labopharm said Angelini has “appropriately addressed all deficiencies cited by the FDA​” and added that the agency has classified the Italian active pharmaceutical ingredient (API) maker’s operation as acceptable.

The original concerns, which emerged in July after a US Food and Drug Administration (FDA) inspection of Angelini’s facility the previous month, had halted the agency’s review of Trazodone.

Details of the observations were not disclosed, although at the time Angelini said that they were not critical, which is a position that appears to have been confirmed by the FDA’s latest decision.

Trazodone demand

The positive news saw Labopharm’s share price surge 33 per cent to $1.81, which is a reflection of the anticipated US demand for once-a-day trazodone for indications such as depression, insomnia and fibromyalgia.

The drug inhibits the reuptake of the neurotransmitter serotonin and is thought to mediate its antidepressant and sedative effects through its antagonistic interaction with a number of key serotonin receptors.

The original version of trazodone, which was discovered by Angelini’s research arm in the early 1960s, was approved by the FDA in 1981 and has since gone on to be marketed worldwide.

And, while trazodone had been somewhat eclipsed by other more powerful antidepressants in recent years, including SSRIs like Prozac (fluoxetine) and Celexa (citalopram) concerns about this type of drug has led to a resurgence of interest.

Labopharm said that the FDA has set a date of February 11, 2010 for the completion of its regulatory review.

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