Apr 7, 9:33 PM (ET)
WASHINGTON (AP) - The fat-blocking drug in Xenical could become available without a prescription later this year, GlaxoSmithKline said Friday 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 Thursday. 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 added.
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 million 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 roughly five pounds to six 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 overall 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.
British-owned GlaxoSmithKline's U.S. operations are based in Philadelphia and Research Triangle Park, N.C.
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