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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR CHANTIX


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505(b)(2) Clinical Trials for Chantix

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT03557294 ↗ Varenicline OTC Trial on Efficacy and Safety Recruiting Los Angeles Clinical Trials Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
OTC NCT03557294 ↗ Varenicline OTC Trial on Efficacy and Safety Recruiting National Institute on Drug Abuse (NIDA) Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
OTC NCT03557294 ↗ Varenicline OTC Trial on Efficacy and Safety Recruiting Pfizer Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Chantix

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00455650 ↗ Study of the Effects of Mecamylamine and Varenicline in Schizophrenia Completed National Alliance for Research on Schizophrenia and Depression N/A 2007-03-01 We are conducting this study to find out if blocking or partially stimulating the effects of nicotine in the brain can affect memory and concentration. Nicotine is the addictive drug found in tobacco products. Our subjects will be people with and without mental illness (schizophrenia), smokers and non-smokers. We will use a medication called mecamylamine (Inversine) to block the effects of nicotine on the brains of our subjects. We will also use a medication called varenicline (Chantix) to partially increase the effects of nicotine on the brains of our subjects. This study also uses a placebo, a pill that does not have any active ingredients but looks exactly like the mecamylamine and varenicline pills. We will compare the effects of giving mecamylamine or placebo to people who have schizophrenia and people who do not have schizophrenia. We know that people with schizophrenia smoke heavily and find it harder to stop smoking than most other people do. Studies have shown that people with schizophrenia may smoke more because nicotine helps their concentration and memory. We are interested in helping people with schizophrenia smoke less. Mecamylamine blocks the parts of the brain that react to nicotine and varenicline partially stimulates and partially blocks the parts of the brain that react to nicotine. Both medications may decrease the effects that smoking has on the body.
NCT00455650 ↗ Study of the Effects of Mecamylamine and Varenicline in Schizophrenia Completed The Bowman Family Foundation N/A 2007-03-01 We are conducting this study to find out if blocking or partially stimulating the effects of nicotine in the brain can affect memory and concentration. Nicotine is the addictive drug found in tobacco products. Our subjects will be people with and without mental illness (schizophrenia), smokers and non-smokers. We will use a medication called mecamylamine (Inversine) to block the effects of nicotine on the brains of our subjects. We will also use a medication called varenicline (Chantix) to partially increase the effects of nicotine on the brains of our subjects. This study also uses a placebo, a pill that does not have any active ingredients but looks exactly like the mecamylamine and varenicline pills. We will compare the effects of giving mecamylamine or placebo to people who have schizophrenia and people who do not have schizophrenia. We know that people with schizophrenia smoke heavily and find it harder to stop smoking than most other people do. Studies have shown that people with schizophrenia may smoke more because nicotine helps their concentration and memory. We are interested in helping people with schizophrenia smoke less. Mecamylamine blocks the parts of the brain that react to nicotine and varenicline partially stimulates and partially blocks the parts of the brain that react to nicotine. Both medications may decrease the effects that smoking has on the body.
NCT00455650 ↗ Study of the Effects of Mecamylamine and Varenicline in Schizophrenia Completed Massachusetts General Hospital N/A 2007-03-01 We are conducting this study to find out if blocking or partially stimulating the effects of nicotine in the brain can affect memory and concentration. Nicotine is the addictive drug found in tobacco products. Our subjects will be people with and without mental illness (schizophrenia), smokers and non-smokers. We will use a medication called mecamylamine (Inversine) to block the effects of nicotine on the brains of our subjects. We will also use a medication called varenicline (Chantix) to partially increase the effects of nicotine on the brains of our subjects. This study also uses a placebo, a pill that does not have any active ingredients but looks exactly like the mecamylamine and varenicline pills. We will compare the effects of giving mecamylamine or placebo to people who have schizophrenia and people who do not have schizophrenia. We know that people with schizophrenia smoke heavily and find it harder to stop smoking than most other people do. Studies have shown that people with schizophrenia may smoke more because nicotine helps their concentration and memory. We are interested in helping people with schizophrenia smoke less. Mecamylamine blocks the parts of the brain that react to nicotine and varenicline partially stimulates and partially blocks the parts of the brain that react to nicotine. Both medications may decrease the effects that smoking has on the body.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Chantix

Condition Name

Condition Name for Chantix
Intervention Trials
Smoking Cessation 44
Nicotine Dependence 38
Smoking 20
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Condition MeSH

Condition MeSH for Chantix
Intervention Trials
Tobacco Use Disorder 62
Alcoholism 14
Schizophrenia 11
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Clinical Trial Locations for Chantix

Trials by Country

Trials by Country for Chantix
Location Trials
United States 166
Canada 7
Israel 3
India 2
Netherlands 2
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Trials by US State

Trials by US State for Chantix
Location Trials
Pennsylvania 21
Minnesota 16
New York 15
Connecticut 15
North Carolina 13
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Clinical Trial Progress for Chantix

Clinical Trial Phase

Clinical Trial Phase for Chantix
Clinical Trial Phase Trials
Phase 4 43
Phase 3 20
Phase 2/Phase 3 11
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Clinical Trial Status

Clinical Trial Status for Chantix
Clinical Trial Phase Trials
Completed 114
Recruiting 13
Withdrawn 10
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Clinical Trial Sponsors for Chantix

Sponsor Name

Sponsor Name for Chantix
Sponsor Trials
National Institute on Drug Abuse (NIDA) 45
Pfizer 33
National Cancer Institute (NCI) 16
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Sponsor Type

Sponsor Type for Chantix
Sponsor Trials
Other 208
NIH 87
Industry 43
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CHANTIX (Varenicline): Clinical Trials, Market Analysis, and Projections

Introduction

CHANTIX (varenicline), developed by Pfizer, is a nicotinic receptor partial agonist designed to aid in smoking cessation. Since its approval in 2006, the drug has undergone extensive clinical trials, faced various challenges, and experienced significant market fluctuations. Here’s an update on the clinical trials, market analysis, and projections for CHANTIX.

Clinical Trials Overview

EAGLES Trial

One of the most significant clinical trials for CHANTIX was the EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) trial. This trial, published in The Lancet, compared the efficacy and safety of CHANTIX, bupropion, nicotine patch, and placebo in smoking cessation. The results showed that patients treated with CHANTIX had significantly higher quit rates than those treated with bupropion, nicotine patch, or placebo. The trial also found no significant increase in serious neuropsychiatric adverse events with CHANTIX relative to the other treatments[1].

Neuropsychiatric Safety

A key focus of the EAGLES trial was to assess the risk of clinically significant neuropsychiatric events, including suicidality, in patients with and without a history of psychiatric disorders. The study concluded that the incidence of these events was not significantly higher with CHANTIX compared to the other treatments or placebo. However, the trial noted that the findings may not generalize to smokers with untreated or unstable psychiatric disease[1][3].

Combination Therapy

Research has also explored the effectiveness of combining CHANTIX with nicotine replacement therapy (NRT). A study published in JAMA found that combination therapy with varenicline and NRT did not significantly outperform varenicline alone in achieving smoking abstinence, although it suggested that longer treatment durations might be beneficial[4].

Pediatric Use

In a phase 4 study required by U.S. and European regulators, CHANTIX did not outperform a placebo in achieving four weeks of continuous abstinence in smokers aged 12 to 19. This study was part of Pfizer's efforts to gain pediatric exclusivity for the drug, but the results were not favorable[2].

Market Analysis

Sales and Revenue

CHANTIX has experienced a mixed market performance over the years. Despite its efficacy in smoking cessation, the drug's sales have been impacted by various factors. In 2016, CHANTIX generated $997 million in sales, an 18% increase from the previous year. However, the price of a 30-day supply of CHANTIX more than doubled to $485 since 2013, which has affected its affordability and accessibility, particularly for low-income populations[2].

Pricing and Coverage

The high cost of CHANTIX, coupled with poor insurance coverage, has been a significant barrier. Many insurers have relegated the drug to tier 3 status on their formularies, resulting in high out-of-pocket costs for patients. This pricing strategy has not been favorable for the estimated 37.8 million Americans who are currently smoking, especially those from low-income backgrounds[2].

Patent Protection and Generic Competition

CHANTIX lost its patent protection in the U.S. in November 2020, which has opened the door for generic competition. Although generic versions have not yet entered the market, Pfizer anticipates this could happen at any time, potentially impacting the drug's sales and market share[5].

Market Projections

Impact of COVID-19

The COVID-19 pandemic has had a notable impact on CHANTIX sales, with a 17% decline from $1.1 billion in 2019 to $919 million in 2020. This decline is attributed to both the pandemic and the loss of patent protection[5].

Nitrosamine Contamination

In 2021, Pfizer paused the global distribution of CHANTIX due to the detection of increased levels of nitrosamines, potentially cancer-causing agents, in the drug. This move, although precautionary, has further complicated the drug's market trajectory. The company is conducting investigations and has recalled several lots of the drug[5].

Future Outlook

Despite the challenges, CHANTIX remains a significant player in the smoking cessation market. Pfizer continues to support ongoing efforts to grow the market for CHANTIX, although the future outlook is uncertain due to the potential for generic competition and the ongoing investigations into nitrosamine contamination.

Key Takeaways

  • Efficacy: CHANTIX has been shown to have higher quit rates compared to other smoking cessation treatments.
  • Safety: The drug has no significant increase in serious neuropsychiatric adverse events relative to other treatments.
  • Market Performance: CHANTIX has experienced fluctuations in sales, influenced by pricing, insurance coverage, and patent protection.
  • Challenges: High costs, poor insurance coverage, and recent concerns over nitrosamine contamination pose significant challenges.
  • Future Projections: The market for CHANTIX is uncertain due to potential generic competition and ongoing safety investigations.

FAQs

What is CHANTIX and how does it work?

CHANTIX (varenicline) is a nicotinic receptor partial agonist that helps reduce cravings for and the pleasurable effects of cigarettes, aiding in smoking cessation.

What were the key findings of the EAGLES trial?

The EAGLES trial found that CHANTIX had higher quit rates compared to bupropion, nicotine patch, and placebo, with no significant increase in serious neuropsychiatric adverse events.

Why has the price of CHANTIX increased significantly?

The price of CHANTIX has more than doubled since 2013, largely due to Pfizer's pricing strategy and the drug's tier 3 status on many insurance formularies.

What is the impact of nitrosamine contamination on CHANTIX?

Pfizer has paused the global distribution of CHANTIX due to the detection of nitrosamines, potentially cancer-causing agents, and has recalled several lots of the drug. This has added uncertainty to the drug's market outlook.

How does CHANTIX compare to other smoking cessation treatments?

CHANTIX has been shown to be more effective than bupropion and nicotine patch in achieving smoking abstinence, but its safety profile and cost have been points of contention.

What are the future market projections for CHANTIX?

The future market for CHANTIX is uncertain due to potential generic competition, ongoing safety investigations, and the impact of the COVID-19 pandemic.

Sources

  1. Pfizer Inc. - CHANTIX®/CHAMPIX® (varenicline) Results from the Largest Global Clinical Trial of Smoking Cessation Medicines Published in The Lancet.
  2. FiercePharma - Price of Pfizer's smoking-cessation drug Chantix doubles in just 5 years.
  3. FDA - CHANTIX (varenicline) tablets, for oral use.
  4. JAMA - Effects of Combined Varenicline With Nicotine Patch and of Extended-Duration Varenicline Therapy.
  5. BioSpace - Pfizer Pauses Global Sales of Smoking-Cessation Drug Chantix Over Possible Carcinogen Contamination.

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