Miracle diet pill? A safe drug is elusive

The FDA rejected the drug in October 2010, raising a number of safety concerns, including higher heart rate and birth defects in women who become pregnant. This week a panel of advisers to the FDA overwhelmingly recommended approval for Qnexa, on the condition Vivus Inc. conduct a follow-up study to make sure the drug doesn’t cause heart problems. The FDA is expected to make its second ruling on the drug by April 17. The company’s results have been lackluster, with about 40 percent of patients taking Contrave losing 5 percent of their body weight. Those figures narrowly achieved FDA’s minimum requirements for an effective weight loss pill.  WASHINGTON For nearly a century, scientists have struggled to make a diet pill that helps people lose weight without side effects that range from embarrassing digestive issues to dangerous heart problems. This week, U.S. federal health advisers endorsed the weight loss pill Qnexa even though the FDA previously rejected it over concerns that it can cause heart palpitations and birth defects if taken by pregnant women. The vote of confidence raises hopes that the U.S. could approve its first anti-obesity drug in more than a decade. It also highlights how challenging it is to create a pill that fights fat in a variety of people without negative side effects.  Qnexa is a combination of the drugs Phentermine, a drug currently approved for weight loss, and topiramate, which is used for the treatment of seizures. It was rejected once by the same committee of doctors in 2010 because of numerous possible side effects, including heart problems and birth defects.

GlaxoSmithKline markets a lower-dose, over-the-counter version called Alli. Both have their side effect issues, including liver problems and uncontrolled bowel movements, and provide only modest weight loss. Qnexa, which combines the appetite suppressant Phentermine and anti-seizure drug topiramate, helped patients lose at least 10 percent of their weight after a year of treatment, the company said. FDA staff reviewers said patients taking the drug had more safety problems, including memory loss and higher heart rates, than those on a placebo, and some of these problems could get worse over time.  As of January 31, about 17.5 percent of Vivus’ shares were held “short” by investors betting the stock will fall. That was down from 18.9 percent in November and down from 24 percent last April. “However, this upside comes with execution and commercial risk.” Simeonidis said that assuming the drug is launched in the third quarter of this year, it could generate sales in the United States and Europe of $2.2 billion by 2019. He also said a big pharmaceutical company could buy Vivus outright. FDA reviewers said patients taking Qnexa had more safety problems, including memory loss and higher heart rates, than those taking a placebo, though Vivus said there is no conclusive link between increased heart rate and heart health.

Vivus Inc’s Qnexa was one of three promising obesity drugs rejected by the U.S. Food and Drug Administration in the past two years over safety concerns. It is the first to come back up for review after more extensive clinical trials, as public health officials urge the FDA to consider a medical treatment for a condition that affects about one-third of Americans. A panel of outside experts to the FDA voted 20-2 to recommend approval of Qnexa, saying they were convinced that the benefits it offers in treating obesity outweighed the potential heart risks and birth defects associated with the drug.  A panel of medical experts voted overwhelmingly Wednesday to endorse the controversial weight-loss drug Qnexa, clearing the way for the Food and Drug Administration to approve a new prescription obesity medication for the first time since 1999. The FDA will issue a final ruling later this year, but the agency typically follows the recommendations of its advisory committees. The 20-2 vote in favor of Qnexa was a surprising reversal from 2010, when the same advisory committee decided that the drug’s risks of heart problems and birth defects outweighed its weight-loss benefits.

A U.S. Food and Drug Administration advisory panel voted 20-to-2 in favor of approval, setting the stage for the FDA to potentially approve the first new weight-loss pill in 13 years and raising hopes that two competing drugs will also be approved. “This is one of the most dramatic developments in pharmacotherapy in a long time,” said Samuel Isaly, managing partner at OrbiMed Advisors, which held 6 million Vivus shares as of December 31. “There have been advances in cancer, lupus, heart disease, but this ranks high in terms of dramatic events, and a lot of smart people are paying attention.” Weighing the drug’s benefit against its potential long-term risk is a task fraught with anxiety for both regulators and investors.  Feb. 23 (Bloomberg)—Vivus Inc. gained the most in 12 years after the company’s pill Qnexa won the backing of a regulatory panel, moving the drug a step closer to gaining U.S. approval as the first new obesity treatment in 13 years. Vivus jumped 78 percent to $18.73 at the close of New York trading, its biggest single-day increase since December 1999. Competitor Orexigen Therapeutics Inc. also rose after the Food and Drug Administration advisers voted 20-2 yesterday that Qnexa’s benefits outweigh its risks.  Feb. 23 (Bloomberg)—Peter Tam, president of Vivus Inc., talks about the outlook for the company’s Qnexa obesity drug after U.S. Food and Drug Administration advisers voted 20-2 yesterday that the pill’s benefits outweigh its risks. 

Qnexa took a step closer to approval on Wednesday, when outside advisers to the U.S. Food and Drug Administration voted 20-to-2 in favor of approval. They also recommended the company conduct a study to scrutinize even more closely any risk of heart problems. That study may be required after the drug is approved. 

“The FDA panel recommended approval of Qnexa only because the ranks of useful weight loss drugs are so thin, and desperate times call for desperate measures.” Though the FDA isn’t required to follow the recommendations of its special panels, it often does. If Qnexa ends up being approved, “FDA scientists said they would require Vivus to train prescribers to educate patients on the pregnancy risks of Qnexa,” says the AP, and only 10 mail-order pharmacies would be permitted to sell the drug.  One of the two ingredients in Qnexa, topirimate, is known to more than double the risk of birth defects. Qnexa’s other ingredient, Phentermine, was one half of the dangerous fen-phen combination, a weight loss treatment pushed by doctors that was never approved by the FDA. The regimen was linked to heart-valve damage and lung problems in the late 1990s, and the FDA forced drugmaker Wyeth to withdraw two versions of its drug fenfluramine. Currently there is just one prescription drug on the market for long-term weight loss: Roche’s Xenical, which is not widely used because of modest weight loss results.  The FDA rejected approval of the drug in 2010, however, because of nagging concerns it may increase the risk of birth defects and heart problems. The FDA reiterated its stance that Qnexa may cause serious side effects. The FDA had said it had concerns about potential side effects of the drug: heart problems and birth defects in the babies of women who take Qnexa while pregnant. The federal agency rejected the drug in October 2010 but its maker, Vivus Inc. of Mountain View, Calif., asked for a chance to present new information. 

For nearly a century, scientists have struggled to make a diet pill that helps people lose weight without side effects that range from embarrassing digestive issues to dangerous heart problems. Earlier this week, a government panel recommended the FDA approve the latest diet drug Qnexa. The FDA has not approved a weight loss drug in the past 13 years, and has removed similar diet pills from the market over concerns about heart risks and other adverse side effects. It’s a prescription medication for weight loss. It helps users shed pounds by suppressing appetite and speeding up metabolism.  While Qnexa has the same potentially dangerous side effects as previously rejected weight loss drugs, the FDA reasoned that the risks posed by obesity were greater still. 

The panel strongly urged the company to do the studies once Qnexa is on the market. “Of all the obesity drugs, this one has the highest efficacy in terms of weight loss, so that shifts the balance in terms of requiring a post-approval study rather than a pre-approval study,” Sanjay Kaul, a professor of cardiology at David Geffen School of Medicine at UCLA Cedars Sinai Medical Center, told Bloomberg. Other panel members were wary of Qnexa’s potential side effects, however, and voted against approval, arguing that more safety studies are needed first. If the agency approves the drug without such data, Dr. Michael Lauer, committee member and director of cardiovascular sciences at the National Heart, Lung and Blood Institute, told the Los Angeles Times, “it would be a decision based on hopes, surrogates and suppositions.”  This week’s big news is the potential arrival of Qnexa, the first new obesity drug to head for tentative FDA approval in 13 years. (The last, Xenical, hit the market in 1999.) Of course, there’s good reason for that; numerous weight loss drugs have been found to have dangerous side effects, causing the FDA to reject them.