CLINICAL TRIALS PROFILE FOR NEXIUM 24HR

505(b)(2) Clinical Trials for Nexium 24hr

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	NCT00443963 ↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	AstraZeneca	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased production of gastric levels of free radicals. The primary objective of the study is to determine if Esomeprazole Magnesium increases gastric total antioxidant capacity and decreases gastric free radical production in humans. Participants (age 18 years and older) with no history of upper GI bleeding who are receiving non-steroidal anti-inflammatory drugs and then develop dyspepsia will be recruited from our primary care clinic in Washington, DC. All eligible participants will undergo biopsies of antrum and corpus. The participants will be randomized to receive either Zantac OTC or Nexium for 15 days. On day 15, all participants will undergo repeat upper endoscopy to obtain biopsies of antrum and corpus. Tissue samples will then be extracted to determine total antioxidant capacity and lipid peroxide levels (as an indirect marker of free radical production).
OTC	NCT00443963 ↗	Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs	Withdrawn	Medstar Health Research Institute	Phase 4	2006-12-01	The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased production of gastric levels of free radicals. The primary objective of the study is to determine if Esomeprazole Magnesium increases gastric total antioxidant capacity and decreases gastric free radical production in humans. Participants (age 18 years and older) with no history of upper GI bleeding who are receiving non-steroidal anti-inflammatory drugs and then develop dyspepsia will be recruited from our primary care clinic in Washington, DC. All eligible participants will undergo biopsies of antrum and corpus. The participants will be randomized to receive either Zantac OTC or Nexium for 15 days. On day 15, all participants will undergo repeat upper endoscopy to obtain biopsies of antrum and corpus. Tissue samples will then be extracted to determine total antioxidant capacity and lipid peroxide levels (as an indirect marker of free radical production).

All Clinical Trials for Nexium 24hr

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00069823 ↗	Study of Acid Reflux in Asthma	Completed	American Lung Association Asthma Clinical Research Centers	Phase 3	2003-09-01	The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.
NCT00069823 ↗	Study of Acid Reflux in Asthma	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	2003-09-01	The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.
NCT00069823 ↗	Study of Acid Reflux in Asthma	Completed	Johns Hopkins Bloomberg School of Public Health	Phase 3	2003-09-01	The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.

Clinical Trial Conditions for Nexium 24hr

Condition Name

Condition Name for Nexium 24hr
Intervention	Trials
GERD	16
Gastroesophageal Reflux Disease	15
Healthy	15

Condition MeSH

Condition MeSH for Nexium 24hr
Intervention	Trials
Gastroesophageal Reflux	47
Esophagitis, Peptic	18
Dyspepsia	14

Clinical Trial Locations for Nexium 24hr

Trials by Country

Trials by Country for Nexium 24hr
Location	Trials
United States	163
Japan	57
Canada	41
Italy	29
Germany	24

Trials by US State

Trials by US State for Nexium 24hr
Location	Trials
Texas	11
California	11
Pennsylvania	8
New York	8
Florida	8

Clinical Trial Progress for Nexium 24hr

Clinical Trial Phase

Clinical Trial Phase for Nexium 24hr
Clinical Trial Phase	Trials
Phase 4	61
Phase 3	34
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Nexium 24hr
Clinical Trial Phase	Trials
Completed	118
Unknown status	14
Terminated	8

Clinical Trial Sponsors for Nexium 24hr

Sponsor Name

Sponsor Name for Nexium 24hr
Sponsor	Trials
AstraZeneca	65
Xijing Hospital of Digestive Diseases	5
Chinese University of Hong Kong	5

Sponsor Type

Sponsor Type for Nexium 24hr
Sponsor	Trials
Industry	115
Other	106
U.S. Fed	4

Nexium 24HR: Clinical Trials, Market Analysis, and Projections

Introduction

Nexium 24HR, a proton pump inhibitor (PPI) containing esomeprazole, has been a significant player in the over-the-counter (OTC) market for heartburn relief since its FDA approval in March 2014. Here, we delve into the clinical trials, market analysis, and projections for this medication.

Clinical Trials and Efficacy

Phase III Trials

The clinical trials for Nexium 24HR involved two key studies to support its OTC indication. These studies evaluated the efficacy of Nexium 24HR in treating frequent heartburn, defined as heartburn occurring two or more days a week. The trials showed that Nexium 24HR provided significant relief compared to placebo.

• In one study, the response rate, defined as the percentage of heartburn-free 24-hour days during 14 days of treatment, was 46.13% for the treatment group versus 33.07% for the placebo group[1].
• The second study reported a response rate of 48.00% for the treatment group versus 32.75% for the placebo group[1].

These results indicate that Nexium 24HR is effective in reducing frequent heartburn symptoms.

Bioequivalence Studies

To ensure the bioequivalence of the OTC Nexium 24HR tablet and capsule formulations, Pfizer conducted a Phase I study. This study used a 6-period crossover design to compare the bioavailability of the tablet and capsule under both fed and fasted conditions. The results showed that the PK parameters of the tablet and capsule were within the acceptable limits, supporting the biowaiver for the OTC Nexium 24HR capsules[1].

Food Effect

The clinical trials also highlighted the importance of taking Nexium 24HR before eating to maximize its efficacy. A food effect study indicated that taking the medication right before eating could reduce esomeprazole exposure, potentially affecting its efficacy[1].

Mechanism of Action

Nexium 24HR works by inhibiting the H+/K+ ATPase enzyme in the gastric parietal cells, thereby blocking the final step in acid production. This mechanism allows esomeprazole, the active ingredient, to provide 24-hour relief from heartburn by suppressing gastric acid secretion more effectively than other antacids or H2 blockers[4].

Market Analysis

Market Size and Demographics

The market for heartburn relief is substantial, with approximately 60 million adults in the U.S. affected by heartburn, including 15 million who experience heartburn daily[2].

Competitive Landscape

Nexium 24HR competes in the OTC PPI market, which also includes products like Prilosec OTC (omeprazole). However, Nexium 24HR has a competitive edge due to its higher bioavailability and longer duration of action compared to omeprazole. Esomeprazole, being the S-isomer of omeprazole, delivers 80% more acid blockers to the source, making it more effective in suppressing acid[4].

Launch and Sales

Pfizer acquired the global rights to Nexium from AstraZeneca in August 2012 and launched Nexium 24HR in May 2014. The launch coincided with the scheduled generic entry date for prescription Nexium, which faced patent expiration in 2015. Despite initial uncertainty about the impact of generic versions, the OTC launch has contributed to Pfizer’s growing OTC portfolio, which includes medications in respiratory therapy, pain management, dietary supplements, and digestive therapy[2][5].

Projections and Future Outlook

Market Impact

The commercial impact of OTC Nexium 24HR was initially expected to be limited, given that the 20mg dose represented only 5-6% of total U.S. prescriptions for Nexium in FY13. However, the imminent arrival of generics for the prescription version could boost the OTC market as managed care formularies reduce reimbursement for drugs approved in the OTC channel[5].

Consumer Satisfaction and Loyalty

Nexium 24HR has been well-received by consumers, with its promise of 24-hour heartburn protection and various convenient formulations, including capsules, ClearMinis, and tablets. The product’s ease of use, recognized by the Arthritis Foundation, adds to its appeal. Additionally, a satisfaction guarantee further enhances consumer confidence in the product[4].

Future Growth

The OTC market for heartburn relief is expected to grow as more consumers seek convenient and effective solutions for frequent heartburn. With its strong brand recognition and clinical efficacy, Nexium 24HR is poised to remain a leading player in this market. The potential shift from prescription to OTC formulations due to cost and accessibility factors could further drive the growth of Nexium 24HR[2][5].

Key Takeaways

• Clinical Efficacy: Nexium 24HR has demonstrated significant efficacy in clinical trials, providing 24-hour relief from frequent heartburn.
• Market Position: It competes effectively in the OTC PPI market due to its higher bioavailability and longer duration of action.
• Consumer Appeal: The product offers various convenient formulations and a satisfaction guarantee, enhancing consumer loyalty.
• Future Outlook: The market for OTC heartburn relief is expected to grow, with Nexium 24HR well-positioned to capitalize on this trend.

FAQs

Q: What is the active ingredient in Nexium 24HR?

A: The active ingredient in Nexium 24HR is esomeprazole, the S-isomer of omeprazole.

Q: How does Nexium 24HR work?

A: Nexium 24HR works by inhibiting the H+/K+ ATPase enzyme in the gastric parietal cells, blocking the final step in acid production.

Q: What is the recommended dosage for Nexium 24HR?

A: The recommended dosage is one capsule or tablet once daily for 14 consecutive days, taken before eating in the morning.

Q: How does Nexium 24HR compare to other heartburn medications?

A: Nexium 24HR provides longer-lasting relief compared to histamine blockers (H2s) and is more effective than omeprazole due to its higher bioavailability.

Q: Is Nexium 24HR available in different formulations?

A: Yes, Nexium 24HR is available in capsule, ClearMini, and tablet forms, as well as an “Easy-Open Cap” bottle recognized by the Arthritis Foundation for ease of use.

Sources

1. FDA Clinical Pharmacology Filing Memo: Nexium 24HR OTC Capsule and Tablet Bioequivalence Study[1].
2. Biopharma Dive: Pfizer Expands OTC Portfolio with Launch of OTC Nexium 24HR[2].
3. FDA Clinical Pharmacology Review: Nexium 24HR OTC Capsule[3].
4. Haleon HealthPartner: Nexium 24HR Overview[4].
5. MM+M: OTC Nexium Launches Amid Generic Uncertainty[5].