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Dr. Bob is Robert Hsiung, MD,
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Posted by jrbecker on May 11, 2006, at 12:50:56
FDA Nod Puffs Up Pfizer
By Robert Steyer
TheStreet.com Staff Reporter
5/11/2006 11:24 AM EDT
URL: http://www.thestreet.com/stocks/pharmaceuticals/10285089.html
The Food and Drug Administration on Thursday approved a new antismoking pill from Pfizer (PFE:NYSE) , continuing the drug giant's recent streak of successful new drug applications.The active ingredient in the drug, to be sold under the brand name Chantix, "is a new molecular entity that received a priority FDA review because of its significant potential benefit to public health," the agency said Thursday.
Pfizer said Chantix, which it called Champix during development, is the first new prescription antismoking drug in nearly a decade. "Smoking harms nearly every organ in the body [and] is responsible for approximately one in five deaths in the U.S.," said Hank McKinnell, Pfizer's chairman and CEO. "This medical advance from Pfizer will now help many smokers end their addiction."
Chantix is the fourth new Pfizer drug to get FDA clearance this year. The others are Exubera, an inhaled insulin for diabetics, which should reach the U.S. market by midyear; the antifungal, Eraxis, for treating dangerous bloodstream infections; and Sutent, for the treating advanced kidney cancer and certain stomach cancer tumors.
In a few days, the company expects to hear from the FDA on Indiplon, an insomnia drug Pfizer has developed with Neurocrine Biosciences (NBIX:Nasdaq) . Pfizer also expects to hear from the FDA this year on it application for Zeven, an antibiotic.
By midmorning, Pfizer's shares were up 9 cents to $25.13.
The Centers for Disease Control and Prevention says an estimated 44.5 million adults in the U.S. smoke cigarettes, and more than 8.6 million of them have at least one serious illness caused by smoking. "Tobacco use, particularly cigarette smoking, is the single most preventable cause of death in the United States and is responsible for a growing list of cancers as well as chronic diseases including those of the lung and heart," said Dr. Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs.
Nicotine addiction is caused when people inhale smoke from cigarettes, sending nicotine rapidly to the brain. The nicotine triggers a reaction that stimulates the pleasure center of the brain. This effect doesn't last very long, thus promoting "a cycle of craving and withdrawal," the FDA says.
Chantix acts at sites in the brain affected by nicotine. The FDA says the drug may help some smokers quit by providing some nicotine effects to reduce the craving and withdrawal symptoms and by blocking the effects of nicotine from cigarettes if people resume smoking. Reducing the enjoyment from smoking could help break the cycle of nicotine addiction.
The FDA approved the twice-a-day Chantix pill based on data that included late-stage clinical trials involving more than 2,000 smokers. On average, they had smoked about 21 cigarettes per day for an average of 25 years.
In two studies, patients who took Chantix for 12 weeks "nearly quadrupled the likelihood of quitting than those taking placebo," Pfizer said. Chantrix users also "had nearly twice the likelihood of quitting" than patients taking buproprion, which is sold under the brand name Zyban by GlaxoSmithKline (GSK:NYSE ADR) .
Patients in the clinical trials received educational materials and were followed for 40 weeks after treatment. After one year, approximately 20% of Chantix users had stopped smoking. "For those patients who quit at the end of 12 weeks, an additional course of 12 weeks treatment with Chantix resulted in a greater likelihood of long-term success in quitting smoking," Pfizer said.
The major side effects detected in clinical trials included nausea, changes in dreaming, constipation, gas and vomiting.
Posted by curtm on May 11, 2006, at 14:53:22
In reply to FDA approves Pfizer's antismoking pill, posted by jrbecker on May 11, 2006, at 11:35:27
Hey jr
That's wonderful. Nothing else really worked for me, including self-control and willpower!
Are there any known drug interactions yet?
Do I just go to my family physician and ask for it?
curtm
Posted by Emily Elizabeth on May 11, 2006, at 23:32:34
In reply to Re: FDA approves Pfizer's antismoking pill » jrbecker, posted by curtm on May 11, 2006, at 14:53:22
Does anyone know what neurotransmitters(?) this drug will work on? I know that it is a different mechanism than Zyban, but I haven't read anywhere abt how this drug actually works.
I'm not a smoker, but I do find this interesting.
Best,
EE
Posted by LOOPS on May 14, 2006, at 9:26:13
In reply to Re: FDA approves Pfizer's antismoking pill, posted by Emily Elizabeth on May 11, 2006, at 23:32:34
if this works without the dreaded insomnia i'll be a taker!
Loops
This is the end of the thread.
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