Vivus now is in middle-stage trials of a metered-dose spray of testosterone, the "male" hormone.
"We are certainly optimistic, " Peter Tam, Vivus' president, said of the chance of having Qnexa approved.
On February 22nd one pharmaceutical firm, Vivus, took a small step towards this goal.
Arena Pharmaceuticals gained 18.9% Friday after competitor Vivus saw its competing weight loss drug rejected by an FDA panel.
The FDA has required Vivus to do a study on the drug's cardiovascular effects.
Meanwhile, Vivus suffered a setback last month when European regulators declined to approve Qsymia ( back story).
The latest example of this is Vivus Inc. ( VVUS), which has a new obesity-fighting drug called Osymia.
The Vivus and Arena drugs were rejected, while an advisory panel recently recommended the Orexigen compound for approval.
This helps explain why Vivus is offering eligible patients a free, 14-day trial for Qsymia for a starting dose.
Indeed, the news goosed Vivus stock slightly, but the measurable impact is not expected to be felt for months.
FORBES: Vivus And Its Diet Pill Get A Needed Break, But Will This Make A Difference?
After considerable anticipation, the FDA has finally eased restrictions on how the Vivus diet pill can be made accessible.
FORBES: Vivus And Its Diet Pill Get A Needed Break, But Will This Make A Difference?
In the panel meeting two days ago, members discussed whether Vivus should conduct further studies before or after approval.
FORBES: New Diet Drug Qnexa Promises 10% Weight Loss - At What Price?
However, the hurdles Vivus says the agency is raising appear to be the type that result in relatively short delays.
Qnexa was invented by Dr. Thomas Najarian in 2003, then a full-time scientist at Vivus who remains at the company part-time.
Vivus shares are taking a hit today on the news that the ingredient in Qnexa is associated with oral cleft defects.
FORBES: Vivus Data Shows Weight Loss Drug Ingredient Associated with Oral Clefts
Instead of generating a blockbuster, however, Vivus has delivered nothing but disappointment.
FORBES: Vivus And Its Diet Pill Get A Needed Break, But Will This Make A Difference?
Consquently, speculation is mounting that Vivus may sell to a larger drugmaker.
For example, he recently gained 455% in VIVUS (VVUS) , after he scooped up distressed shares of the weight-loss-drug maker in 2010.
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Another obesity drug, Qnexa from Vivus Pharmaceuticals, ran into trouble because an FDA panel wanted its REMS to be even more restrictive than it was.
On the Nasdaq, take-over discussions have boosted Vivus shares by 2%.
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This summer, FDA panels rejected drugs from Arena Pharmaceuticals and Vivus.
If the FDA is not convinced that Vivus has a good handle on the potential for cardiovascular risk, that could slow things down a great deal.
The FDA and Vivus both acknowledge that the three clinical trials meant to measure Qsymia's safety and effectiveness were not designed to properly assess cardiovascular risk.
Vivus has proposed a program to educate women of childbearing age about the risk of Qnexa and the need to use birth control while taking it.
But in the absence of an increased sales presence to take advantage of the wider distribution, Vivus is unlikely to significantly expand sales in a meaningful way.
FORBES: Vivus And Its Diet Pill Get A Needed Break, But Will This Make A Difference?
Vivus was the first of three obesity drugs to go before FDA advisory panels in the second half of this year, and the first to be rejected.
This is particularly important for investors waiting for an FDA decision after a panel, such as those who have money in obesity drug companies Arena Pharmaceuticals and Vivus.
When FDA rejected Qnexa in 2010, the agency asked Vivus for two-year clinical data clinical data rather than the one year's worth of data that was available then.
This poses both a challenge and an opportunity for Vivus.
FORBES: Vivus And Its Diet Pill Get A Needed Break, But Will This Make A Difference?
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