Pharmacia's Vestra "not approvable"

Pharmacia has failed in its attempt to get its antidepressant Vestra(reboxetine mesylate) approved by the US Food and Drug Administration, which has sent the firm a "not approvable" letter for the drug, despite the fact that it is already marketed in 50 countries around the world. The blow came just 24 hours after some other bad news for the company with regard to its anticancer drug Camptosar (see page 20).

Pharmacia has not revealed the reason for the FDA's action, but noted that the agency has agreed to convene an advisory committee meeting later this year to review the Vestra submission. The company first submitted the New Drug Application for Vestra to the FDA in 1998 and, in 1999, was granted a preliminary approval on the back of clinical data generated outside North America. The agency asked Pharmacia to conduct additional studies of the antidepressant in the USA and Canada, but these new data have not been deemed sufficient to support approval.

Vestra is a minor drug for Pharmacia, despite optimism when it was first launched in 1997 that its unique mechanism of action, the inhibition of norepinephrine reuptake, would help it carve out a niche in the competitive antidepressant market. Norepinephrine depletion in depressed patients is thought to correlate closely with lackluster energy levels and loss of motivation, which can make it hard for patients to break out of the cycle of depression. Despite this point of difference, sales of the drug have been disappointing, coming in at something under $100 million annually.