FDA Advisors Recommend Against VIVUS Diet Pill; Cite Safety Concerns

By on July 27, 2010

VivusShares of VIVUS, Inc. (NASDAQ: VVUS), a California-based biopharmaceutical company, fell 55%, from $12.11 down to $5.41, after a panel of outside advisors to the FDA recommended last Friday against approval of its Qnexa diet pill for safety concerns. VIVUS develops therapies for obesity, diabetes, and sexual health.

Noted side effects of the drug included possible psychiatric problems, like depression and suicidal thinking, impaired memory and concentration, acid buildup in bodily fluids that could increase the risk of kidney stones, and increase in heart rate that could cause cardiac problems and possible birth defects.  Panel members said longer-term safety data would make them more comfortable about supporting the drug.

Panel member Lamont Weide, chief of endocrinology at Truman Medical Centers in Kansas City, Missouri, stated in a Bloomberg article:

As much as I feel for the people who want this drug and want to lose weight, we have to protect the population at large. We need longer-term data in the people who are really going to be using the drug out there.

During a May 3, 2010 conference call, VIVUS CEO Leland F. Wilson downplayed these very safety concerns when questioned by Thomas Wei, an analyst with Jeffries.:

When asked how many major cardiovascular adverse events occurred against the placebo, Wilson said:

We do not have the final data on those at this point. We’re hopeful to have them by the advisory panel, but that’s something that’s outside of our hands right now because of an independent adjudication committee. We feel very strongly, as you know, that the cardiovascular benefits of this drug are really outstanding.  And so we’re anxious to present our cardiovascular data.

Wilson later stated he was confident the review of adverse psychiatric events due to the drug was thorough and convincing, adding the depression exhibited was primarily mild and manageable and resolved in the majority of cases.

“We have presented all the data that we have on our psychiatric AEs to this point,” he stated. “Clearly, we have probably the most thorough and complete look at  both depression and suicidality of any product that’s ever been through the FDA in the Phase 3 program. And clearly, we really have a zero indication of any suicidality. …

The FDA is scheduled to decide whether to clear Qnexa on October 28, 2010.

Update

On October 28, 2010, after the markets closed, VIVUS said the FDA rejected its weight-loss drug Qnexa, a move that was in line with a July advisory panel decision, and has requested information on Qnexa’s potential to cause birth defects, evidence that an elevated heart rate associated with the drug doesn’t signal heightened cardiovascular risk and the complete results of a longer-term study of the drug.

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