Weight-loss pill to win FDA sanction?
May 5, 2006
WASHINGTON - The fat-blocking drug in Xenical could become available without a prescription later this year, GlaxoSmithKline said after federal health officials told the company the potential blockbuster pill was “approvable.”
That interim step means the over-the-counter form of the drug, called orlistat, is eligible for final approval by the Food and Drug Administration. Approvable letters typically ask a company to meet certain conditions before its product can receive a final OK.
GlaxoSmithKline Consumer Healthcare spokeswoman Malesia Dunn refused to disclose what the FDA had asked of the company in the approvable letter, received late last week. The company planned to meet with the FDA in coming weeks and hoped to introduce the drug, under the brand name “Alli,” in the second half of the year, Dunn said.
If the FDA approves orlistat as a nonprescription drug, it would become the first such weight-loss pill to win the agency’s sanction. In January, two FDA panels of outside experts voted 11-3 to recommend that the agency approve orlistat for over-the-counter use.
Alli would contain half the dose of Xenical prescription capsules and would cost consumers $12 to $25 a week, GlaxoSmithKline has said. The company estimated 5 to 6 million Americans a year would buy the drug if offered over the counter. Those numbers could mean at least $1.5 billion a year in retail sales.
Orlistat works when taken with meals by blocking the absorption of about one-quarter of any fat consumed. That fat - the equivalent of about 150 to 200 calories - is passed out of the body in stools, which can be loose as a result. About half of the patients in trials experienced gastrointestinal side effects, including fecal incontinence, gas and oily discharge.
In those trials, obese people who took the pills lost about 5 to 6 pounds more than did those who were given dummy pills. Once they ceased taking the drug, its effect stopped and the patients began to regain the weight they had lost.
GlaxoSmithKline wants people to use Alli for only six months at a time as part of an comprehensive diet and exercise regimen.
The company licensed orlistat from Roche to develop the nonprescription version. Roche has sold Xenical, a prescription version of the drug, since the FDA approved it in 1999. Roche plans to continue selling Xenical.
Earlier this week, the private group Public Citizen asked health officials to ban Xenical, citing a link to what some scientists believe are precancerous lesions in the large intestine.
A petition to the FDA asks only to have Xenical removed from the market. The group previously opposed allowing orlistat to be sold over the counter.
Sidney Wolfe, director of Public Citizen’s Health Research Group, said scientific studies in rats linked orlistat to increased numbers in the colon of aberrant crypt foci, or microscopic lesions that some experts say are precancerous.
Roche did not return telephone and e-mail messages seeking comment.
Studies in rats and mice given the equivalent of dozens of times the human dose of orlistat found no evidence of the drug causing cancer, according to its FDA-approved labeling information.
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