¶ 8:08 AMAlliReport.com Provides Latest News About Over-the-Counter Alli, Low-Dose XenicalAlliReport.com, an independent news site published by Medical Week News, Inc., provides the latest news about Alli, trade name for low-dose Xenical. Alli, which is half the strength of prescription Xenical (orlistat), is seeking approval to become the first prescription weight-loss drug to be sold over-the-counter. Medical Week News also publishes the highly rated site, AcompliaReport.com, reporting on the new prescription weight-loss drug, Acomplia (rimonabant).
Washington, DC (PRWEB) January 23, 2006 -- Medical Week News, Inc., publisher of the highly rated Acomplia Report (http://www.acompliareport.com), announced it has launched a new guide to weight-loss drugs called Alli Report (http://www.allireport.com) to cover latest news about the new over-the-counter version of the prescription weight-loss medication Xenical (orlistat).
With Alli awaiting U.S. Food and Drug Administration (FDA) approval to be sold without a prescription, we believe a growing number of Americans will soon be searching for independent, objective news and information about the benefits and risks of taking this low-dose version of Xenical, said Milton R. Benjamin, publisher of Alli Report (http://www.allireport.com).
We intend to provide all the positive and negative expert opinions on the use of Alli just as our other obesity publication, Acomplia Report (http://www.acompliareport.com), provides all the news about the prescription drug rimonabant as it makes its way through the FDA and European approval processes, Benjamin added.
The Alli Report (http://www.allireport.com) will be updated daily by Medical Week News, and will keep readers fully informed on the FDA approval process, and when this over-the-counter version of low-dose Xenical will be available to the public.
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Press Contact: Milton Benjamin
Company Name: MEDICAL WEEK
Email: email protected from spam bots
Phone: 772-559-4187
Website: www.allireport.com
FDA Raises Warning Flags on Over-the-Counter Sale of Low-Dose Xenical
The U.S. Food and Drug Administration (FDA) staff has raised a variety of warning flags in advance of an advisory committee meeting set for Jan. 23rd to consider GlaxoSmithKline's petition to sell a half-dose version of the diet drug Xenical (orlistat) without a prescription. The FDA staff, in documents released on Jan. 19th, questioned whether the proposed six-month treatment with the over-the-counter version of the drug would be beneficial for a "chronic" condition like obesity.
The staff's comments were being scrutinized particularly closely by those awaiting an FDA decision on whether to approve the new prescription weight-loss drug Acomplia (rimonabant).
While the FDA reviewers did not dispute that the new version of Xenical helped more patients lose weight than those on placebo, they said "there is no evidence presented that a modest, transient weight loss due to orlistat will afford any long-term clinical benefit through either a change in behavior or a reduced risk of serious clinical diseases manifested by being overweight.
"It is difficult to define the clinical benefits of short-term treatment with orlistat," the FDA said. "Although not studied by the sponsor, it is well known that once weight-loss treatment is stopped, lost weight is quickly regained and improvements in co-morbidities become undone."
Patients in clinical trials of Acomplia achieved impressive weight-loss gains in the first year of taking the drug, but for the most part regained the weight in the second year if they stopped taking it.
In addition, the FDA staff expressed concern that the OTC version of Xenical, which would be marketed under the name Alli, might be taken by some type 2 diabetics (many of whom are overweight) and other patients that did not understand the risk after reading the label.
In a study cited by the reviewers, only one-third of those taking diabetes medication correctly stated that they should not use orlistat, and only half the people taking the blood-thinner warfarin correctly understood that they should not use it.
If the FDA, which generally follows the counsel of its advisory committees, ultimately approves Alli, it will be the only FDA-endorsed weight-loss drug available without a prescription.
Report Says Acomplia Still Must Overcome "Skepticism About Its Side Effects"
An article set for publication in the respected journal, Nature Medicine, says that while Acomplia (rimonabant) may turn out to be the "Prozac of obesity," it still faces the challenge of overcoming "skepticism about its side effects." The article notes the troubled past of obesity drugs, ranging from misuse of amphetamines to the "fen-phen debacle of the mid-1990s, when one component of the popular pill combination was foundbut only after several years on the marketto cause irreversible heart valve damage."
While the developer of Acomplia, Sanofi-Aventis, has two years of safety data from clinical trials that concluded last year, U.S. and European regulators currently weighing approval of the drug are thought to still be concerned about the possibility of adverse effects developing during long-term usage.
Participants who lost significant amounts of weight in clinical trials of Acomplia regained the weight when they stopped taking the pill, suggesting that to keep weight off, people will have to continue on Acomplia indefinitely.
The most common side effects reported during the Acomplia clinical trials were nausea, dizziness, diarrhea and joint pain, which researchers described as "mild and transient."
But Nature Medicine reports that when drugs target the central nervous system to control appetite, "how they influence peripheral function only comes out after people have been on the drugs for a period of time," according to Jeffrey Bland, president of Metagenics, a California-based maker of nutritional products.
The journal also took note of reports by researchers that ten participants taking Acomplia in the clinical trials dropped out because of depression, compared to two participants in the clinical trials taking placebos.
"In a 2005 survey of 142 doctors conducted by Decision Resources, a Massachusetts-based pharmaceutical market research firm, more than 80 percent listed depression triggered by the drug as their primary concern; insomnia ran a distant second at 45 percent," the journal reported.
