Despite its propensity to upset some people's stomachs and send them dashing to the bathroom, a new weight-loss treatment called Alli seems poised to become the next big lifestyle drug. It's the first over-the-counter diet product approved by Food & Drug Administration. As such, it's bound to appeal to people who want to shed pounds before a big event such as a wedding and to women who yearn to be as rail-thin as runway models.
This is a problem for Steven Burton, vice-president of the weight control division for GlaxoSmithKline (GSK ) Consumer Healthcare, which markets Alli (pronounced ally). He cringes at the idea of people who don't have a medical problem with their weight latching onto Alli. And he's nervous that the hype surrounding the drug will position it as a quick fix--something it is not. "People have to understand this is not about losing 30 pounds in three weeks," he says.
Try as they might to distance themselves from the controversial term "lifestyle drugs," pharmaceutical companies are putting ever more energy into developing such products. The renewed excitement is most evident in four treatment areas that account for the bulk of lifestyle-drug sales: weight loss, hair loss, sleep, and sexual dysfunction.
This trend is surprising because such treatments can expose patients to risks, sparking criticism of drug companies at a time when patient safety is already under a spotlight. Lifestyle drugs are defined loosely as products used to treat conditions that are not life-threatening. Because people take them over long periods of time, sometimes on a daily basis, they may be more dangerous than they first appear. On June 13 a panel of FDA advisers voted unanimously not to recommend a weight-loss treatment called Acomplia, from Sanofi-Aventis (SNY ). Though it is already approved in 37 countries, the FDA and its advisers are concerned about reports linking it to depression and even suicidal tendencies.
Glaxo managed to dodge such obstacles with Alli, but the drug certainly comes with some baggage. It prevents the body from digesting about a quarter of the fat a person consumes, so those who eat too much fat while taking it can experience unpleasant side effects such as diarrhea. The good news is this will effectively force patients to stick to a low-fat diet while on the treatment, says Glaxo's Burton, and discourage them from using it casually. He declines to estimate what the drug might be worth, but sales of herbal weight-loss pills and other such products that are not regulated by the FDA come to about $1 billion a year. Add in diet foods and programs such as Jenny Craig Inc. (NSRGY ), and the market exceeds $40 billion a year.
Even when government regulators raise alarms about safety, lifestyle drugs often prove irresistible. Millions of Americans, for example, routinely pop sleep medications, even though they are rarely troubled by insomnia, and the crutch is hard to give up. Last year several users of Ambien, from Sanofi-Aventis, reported bizarre incidents in which they consumed meals and drove their cars while asleep. The FDA demanded that Sanofi and all other producers of sleep drugs add strong warnings to their labels. In March the agency further requested that they send letters to doctors notifying them of the warnings and that they print guides for patients that describe the side effects and provide advice on how to use the drugs safely. Undaunted, Americans consumed more than $700 million worth of Ambien in the first quarter of this year, a 54% jump over the same quarter in 2006. All told, prescriptions for Ambien, Sepracor Inc.'s (SEPR ) Lunesta, and similar drugs jumped 15% last year, to 47.8 million, according to health-care information provider IMS Health Inc. (RX ), and total sales grew 29%, to $3.6 billion.
David F. Dinges, a sleep scientist at the University of Pennsylvania, suspects doctors are incorporating the warnings into their consultations with patients rather than withholding the drugs altogether. "They're being more vigilant about side effects, but I don't expect this will lead to a market reduction," says Dinges, who is a scientific adviser to several pharmaceutical companies. On Apr. 20, shortly after Ambien's patent expired, 13 generic drugmakers rushed into the market with copycat versions.
The flip side of insomnia is daytime drowsiness, another attractive target for makers of lifestyle drugs. Provigil, a drug from Cephalon Inc. (CEPH ) that conquers such sensations, saw sales rise 35% in the first quarter of 2007, to $201 million. While Provigil is approved narrowly to treat narcolepsy and other recognized disorders, analysts estimate as much as 90% of its sales come from people who are using it "off-label" to stay awake for long stretches of time. Such usage isn't illegal, but it probably played into the FDA's protracted deliberations over a long-acting version of the drug, called Nuvigil. In addition, some patients developed skin rashes during a trial for a version of Provigil that was being tested to treat attention deficit disorder. The FDA requested that Cephalon add warnings about the side effects to Nuvigil's label before finally approving it on June 18.
Baldness is a lifestyle drug market just waiting for a catalyst. Millions of men in the U.S. are destined to lose most of their hair, but the treatment market today is a mere $1 billion a year. That may be because drugs with high brand awareness, such as Rogaine and Propecia, rarely deliver luxuriant growth. Pfizer Inc. (PFE ) hopes to address this deficit with a potion, now in clinical trials, that was originally developed to treat asthma. "The compound was not well-suited [to treating] this disease, but we are now exploring its potential" in hair loss, says Pfizer spokesman Stephen Lederer in an e-mail. A second baldness treatment from Pfizer is further back in the pipeline.
It was Pfizer that pioneered the lifestyle category back in 1998 with its impotence blockbuster Viagra, and sales are still going strong. Men swallowed $434 million worth of the little blue pills in the first three months of 2007, up 11% over the same period last year. First-quarter sales of Viagra's two competitors, Eli Lilly & Co.'s (LLY ) Cialis and GlaxoSmithKline's Levitra, also grew by double digits.
Now, Johnson & Johnson (JNJ ) is preparing to enter the market for sexual dysfunction. For years it has been testing a drug called Dapoxetine, derived from common antidepressant medications, for premature ejaculation. The FDA declined to approve the drug in 2004, questioning whether the condition really required medical attention. To gain overseas approval, the company ran a number of additional trials, and the results have been so encouraging that J&J may approach the FDA a second time. As Dr. Paul Stoffels, chairman of global research and development for the company's pharmaceutical division, told a gathering of Wall Street analysts in June: "We have generated data to show Dapoxetine provides a relevant benefit to patients."
By Arlene Weintraub