FDA Approves Novel Medication for Smoking Cessation
The U.S. Food and Drug Administration (FDA) announced today the approval of Chantix (varenicline tartrate) tablets, to help cigarette smokers stop smoking. The active ingredient in Chantix, varenicline tartrate, is a new molecular entity that received a priority FDA review because of its significant potential benefit to public health.
Chantix acts at sites in the brain affected by nicotine and may help those who wish to give up smoking in two ways: by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if they resume 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 Scott Gottlieb, MD, Deputy Commissioner for Medical and Scientific Affairs. "The agency is committed to helping facilitate the development of products to help people quit smoking and improve their overall quality of life."
According to the Centers for Disease Control and Prevention (CDC), an estimated 44.5 million adults in the United States smoke cigarettes and more than 8.6 million of them have at least one serious illness caused by smoking.
"Cigarette smoking is a very difficult habit to break due in large part to nicotine dependence or addiction" said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "Chantix therapy has proven to be effective in smokers motivated to quit and will provide another tool for physicians to use for the millions of smokers who want to quit."
The effectiveness of Chantix in smoking cessation was demonstrated in six clinical trials, which included a total of 3659 chronic cigarette smokers who were treated with varenicline. Five of the six studies were randomized, controlled clinical trials in which Chantix was shown to be superior to placebo in helping people quit smoking. These smokers had previously averaged 21 cigarettes a day for approximately 25 years. In two of the five placebo-controlled studies, Chantix-treated patients were also more successful in giving up smoking than patients treated with Zyban (bupropion).
The approved course of Chantix treatment is 12 weeks. Patients who successfully quit smoking during Chantix treatment may continue with an additional 12 weeks of Chantix treatment to further increase the likelihood of long-term smoking cessation.
In clinical trials, the most common adverse effects of Chantix were nausea, headache, vomiting, flatulence (gas), insomnia, abnormal dreams, and dysgeusia (change in taste perception).
Chantix is manufactured and distributed by Pfizer, Inc., New York, NY.
In clinical trials, the most common adverse effects of Chantix were nausea, headache, vomiting, flatulence (gas), insomnia, abnormal dreams, and dysgeusia (change in taste perception).
Hmmm, I wonder just how common these side effects are? I can see some of them being rather offputting to say the least. Intrigued by the idea of 'abnormal dreams' though...I mean what the hell is a normal dream?
During the premarketing development of CHANTIX, over 4500 individuals were
exposed to
CHANTIX, with over 450 treated for at least 24 weeks and approximately 100 for a year.
Most study participants were treated for 12 weeks or less.
In Phase 2 and 3 placebo-controlled studies, the treatment discontinuation rate due to
adverse events in patients dosed with 1 mg BID was 12% for CHANTIX compared to
10% for placebo in studies of three months treatment. In this group, the discontinuation rates for the most common adverse events in CHANTIX treated patients were as follows:
nausea (3% vs. 0.5% for placebo), headache (0.6% vs. 0.9% for placebo), insomnia
(1.2% vs. 1.1% for placebo), and abnormal dreams (0.3% vs. 0.2% for placebo).
Adverse Events were categorized using the Medical Dictionary for Regulatory Activities
(MedDRA, Version 7.1).
The most common adverse events associated with CHANTIX (>5% and twice the rate
seen in placebo-treated patients) were nausea, sleep disturbance, constipation, flatulence,
and vomiting.
Smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms.
The most common adverse event associated with CHANTIX treatment is nausea. For patients treated to the maximum recommended dose of 1 mg BID following initial dosage titration, the incidence of nausea was 30% compared with 10% in patients taking a comparable placebo regimen. In patients taking CHANTIX 0.5 mg BID following initial titration, the incidence was 16% compared with 11% for placebo. Nausea was generally
described as mild or moderate and often transient; however, for some subjects, it was persistent throughout the treatment period.
Table 3 shows the adverse events for CHANTIX and placebo in the 12 week fixed dose
studies with titration in the first week (Studies 2 (titrated arm only), 4, and 5). MedDRA
High Level Group Terms (HLGT) reported in 5% of patients in the CHANTIX 1 mg BID dose group, and more commonly than in the placebo group, are listed, along with
subordinate Preferred Terms (PT) reported in 1% of CHANTIX patients (and at least
0.5% more frequent than placebo). Closely related Preferred Terms such as Insomnia, initial insomnia, Middle insomnia, Early morning awakening were grouped, but individual patients reporting two or more grouped events are only counted once.
Table 3: Common Treatment Emergent AEs (%) in the Fixed-Dose, Placebo-Controlled Studies ( 1% in the 1 mg BID CHANTIX Group, and 1 mg BID CHANTIX at least 0.5% more than Placebo)
SYSTEM ORGAN CLASS
High Level Group Term
Preferred Term
CHANTIX
0.5 mg BID N=129
CHANTIX 1 mg BID N=821
Placebo N=805
* Includes PTs Abdominal (pain, pain upper, pain lower, discomfort, tenderness, distension) and Stomach
discomfort
** Includes PTs Insomnia/Initial insomnia/Middle insomnia/Early morning awakening
The overall pattern, and the frequency of adverse events during the longer-term trials was very similar to that described in Table 3, though several of the most common events were reported by a greater proportion of patients. Nausea, for instance, was reported in 40% of patients treated with CHANTIX 1 mg BID in a one-year study, compared to 8% of placebo-treated patients.
Following is a list of treatment-emergent adverse events reported by patients treated with CHANTIX during all clinical trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening.
BLOOD AND LYMPHATIC SYSTEM DISORDERS. Infrequent: Anemia,
Lymphadenopathy. Rare: Leukocytosis, Thrombocytopenia, Splenomegaly.
I'm sure as hell glad that I didn't take that shit. It's been sitting in my cupboard for about a month now. To hell with all of that. Smoke on I say, smoke on.
15-05-2006, 20:25
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