CLINICAL TRIALS PROFILE FOR ADVIL DUAL ACTION WITH ACETAMINOPHEN

505(b)(2) Clinical Trials for ADVIL DUAL ACTION WITH ACETAMINOPHEN

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	NCT04694300 ↗	OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients	Recruiting	Bayer	Phase 4	2021-02-07	This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.
OTC	NCT04694300 ↗	OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients	Recruiting	University of Pennsylvania	Phase 4	2021-02-07	This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.
OTC	NCT03997851 ↗	Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects	Completed	University of Miami	Phase 1/Phase 2	2019-07-22	Currently, topical antihistamines and corticosteroids are mainly used for itching relief. However, the over the counter antihistamines are not effective on all itch conditions. Acetaminophen is a popular and widely used OTC drug for pain relief. Although its mode of action is still unknown, recent studies have shown that acetaminophen indirectly activates cannabinoid CB1 receptors. Recent studies have shown that topical cannabinoid agonists are effective for itch relief, the efficacy of topical acetaminophen will be tested for non-histaminergic itch relief.

All Clinical Trials for ADVIL DUAL ACTION WITH ACETAMINOPHEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00152854 ↗	Acetaminophen for Cancer Pain	Completed	University Health Network, Toronto	Phase 3	2005-07-01	Many patients with cancer pain have pain not fully controlled on opioids (eg. morphine). The addition of acetaminophen (Tylenol) to opioids in a small study in cancer patients demonstrated better pain control without an increase in side effects. This study will determine if regular acetaminophen improves pain control when added to strong opioids in patients with cancer pain.
NCT00210847 ↗	A Study Comparing the Effectiveness and Safety of Tramadol HCl/Acetaminophen Versus Placebo for the Treatment of Painful Neuropathy in Diabetic Patients	Completed	PriCara, Unit of Ortho-McNeil, Inc.	Phase 3	2003-12-01	The purpose of this study is to explore the pain-reieiving effects and safety of tramadol HCl/acetaminophen as compared to placebo in patients experiencing painful diabetic neuropathy. Treatment of neuropathic pain often requires the use of more than one medication. The pain-relieving potential of tramadol HCl/acetaminophen for the treatment of painful diabetic neuropathy comes from the multiple mechanisms of action in this combination pain medication. Patients who experience painful diabetic neuropathy will be enrolled in this study.
NCT00210847 ↗	A Study Comparing the Effectiveness and Safety of Tramadol HCl/Acetaminophen Versus Placebo for the Treatment of Painful Neuropathy in Diabetic Patients	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2003-12-01	The purpose of this study is to explore the pain-reieiving effects and safety of tramadol HCl/acetaminophen as compared to placebo in patients experiencing painful diabetic neuropathy. Treatment of neuropathic pain often requires the use of more than one medication. The pain-relieving potential of tramadol HCl/acetaminophen for the treatment of painful diabetic neuropathy comes from the multiple mechanisms of action in this combination pain medication. Patients who experience painful diabetic neuropathy will be enrolled in this study.

Clinical Trial Conditions for ADVIL DUAL ACTION WITH ACETAMINOPHEN

Condition Name

Condition Name for ADVIL DUAL ACTION WITH ACETAMINOPHEN
Intervention	Trials
Pain	6
Pain, Postoperative	6
Postoperative Pain	4

Condition MeSH

Condition MeSH for ADVIL DUAL ACTION WITH ACETAMINOPHEN
Intervention	Trials
Pain, Postoperative	17
Acute Pain	6
Osteoarthritis	4

Clinical Trial Locations for ADVIL DUAL ACTION WITH ACETAMINOPHEN

Trials by Country

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−

Trials by Country for ADVIL DUAL ACTION WITH ACETAMINOPHEN
Location	Trials
United States	58
Canada	10
Brazil	4
Egypt	3
France	3

Trials by US State

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−

Trials by US State for ADVIL DUAL ACTION WITH ACETAMINOPHEN
Location	Trials
New York	12
Pennsylvania	8
Texas	6
California	6
Florida	3

Clinical Trial Progress for ADVIL DUAL ACTION WITH ACETAMINOPHEN

Clinical Trial Phase

Clinical Trial Phase for ADVIL DUAL ACTION WITH ACETAMINOPHEN
Clinical Trial Phase	Trials
Phase 4	26
Phase 3	16
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ADVIL DUAL ACTION WITH ACETAMINOPHEN
Clinical Trial Phase	Trials
Completed	47
Recruiting	13
Not yet recruiting	10

Clinical Trial Sponsors for ADVIL DUAL ACTION WITH ACETAMINOPHEN

Sponsor Name

Sponsor Name for ADVIL DUAL ACTION WITH ACETAMINOPHEN
Sponsor	Trials
University of Pennsylvania	4
Sunnybrook Health Sciences Centre	3
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	3

Sponsor Type

Sponsor Type for ADVIL DUAL ACTION WITH ACETAMINOPHEN
Sponsor	Trials
Other	106
Industry	22
U.S. Fed	9

Advil Dual Action with Acetaminophen: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction

In 2020, GlaxoSmithKline (GSK) introduced a groundbreaking over-the-counter (OTC) pain relief medication, Advil Dual Action with Acetaminophen, marking a significant innovation in the U.S. oral pain relief category. This article delves into the clinical trials, market analysis, and future projections for this dual-action pain reliever.

Clinical Trials and Efficacy

The approval of Advil Dual Action was based on a robust set of clinical data. The submission included results from seven clinical studies, with three pivotal efficacy and safety studies focusing on pain relief[1][3][5].

• Efficacy: These studies demonstrated that the fixed-dose combination of ibuprofen and acetaminophen achieved superior efficacy compared to using either ingredient alone. The combination showed appreciable improvements in acute pain symptoms across multiple pre-specified endpoints[1][3][5].
• Mechanism of Action: Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), targets pain at the source by reducing the production of prostaglandins, which cause swelling and pain signals. Acetaminophen, on the other hand, blocks the transmission of pain signals to the brain[1][3][4].
• Safety Profile: The clinical trials indicated a favorable safety profile for Advil Dual Action, with no serious adverse events or deaths reported. The most commonly reported adverse events were mild or moderate and occurred more frequently in the placebo group[4].

Market Analysis

Market Impact

The launch of Advil Dual Action marked the first FDA-approved OTC combination of ibuprofen and acetaminophen in the United States. This innovation has significantly impacted the pain relief market:

• Consumer Demand: The combination of two well-established pain relievers in one tablet has resonated with consumers seeking effective and convenient pain management solutions[2].
• Competitive Advantage: As the first and only OTC medication to combine ibuprofen and acetaminophen, Advil Dual Action has carved out a unique niche in the market, differentiating itself from other pain relief products[2][3].

Market Trends

The pain relief market is driven by several key trends:

• Increasing Demand for OTC Solutions: Consumers are increasingly seeking over-the-counter solutions for managing minor aches and pains, driven by convenience and cost-effectiveness[2].
• Preference for Combination Products: The success of Advil Dual Action indicates a consumer preference for products that combine multiple active ingredients to provide comprehensive pain relief[2].

Market Projections

Growth Potential

Given its unique formulation and strong clinical backing, Advil Dual Action is poised for significant growth:

• Market Share: As the first and only product of its kind, Advil Dual Action is likely to capture a substantial share of the OTC pain relief market. Its superior efficacy and convenience are expected to attract a large customer base[2][3].
• Expansion into New Markets: While initially launched in the United States, there is potential for expansion into other global markets, further increasing its market reach and revenue[2].

Consumer Adoption

Consumer adoption is expected to be high due to several factors:

• Brand Recognition: The Advil brand is well-established and trusted, which will help in rapid adoption of the new product[4].
• Effective Marketing: GSK’s marketing efforts, including educational campaigns about the dual-action mechanism, are likely to drive consumer awareness and adoption[2].

Key Benefits and Differentiators

Fast, Long, and Strong Pain Relief

Advil Dual Action offers a fast onset of action, providing up to 8 hours of tough pain relief. This is superior to using either ibuprofen or acetaminophen alone[4].

Lower Maximum Daily Doses

The combination product requires lower maximum daily doses of each medication compared to taking them separately. For example, the maximum daily allowance of ibuprofen is 750 mg with Advil Dual Action, compared to 1200 mg when taken alone. Similarly, the maximum daily allowance of acetaminophen is 1500 mg, compared to 4000 mg when taken alone[4].

Safety and Efficacy

The product has a favorable safety profile, consistent with the known profiles of each active ingredient. No new safety concerns were identified in the clinical trials[4].

Key Takeaways

• Clinical Efficacy: Advil Dual Action has demonstrated superior efficacy in clinical trials compared to using ibuprofen or acetaminophen alone.
• Market Impact: The product has carved out a unique niche in the OTC pain relief market, driven by consumer demand for effective and convenient solutions.
• Growth Potential: With its strong clinical backing and unique formulation, Advil Dual Action is poised for significant growth in the market.
• Consumer Benefits: The product offers fast, long-lasting pain relief with lower maximum daily doses of each medication, enhancing safety and efficacy.

FAQs

Q: What is Advil Dual Action with Acetaminophen?

A: Advil Dual Action with Acetaminophen is an over-the-counter pain relief medication that combines ibuprofen and acetaminophen in one tablet.

Q: How does Advil Dual Action work?

A: Ibuprofen targets pain at the source by reducing prostaglandins, while acetaminophen blocks pain signals to the brain.

Q: What are the benefits of using Advil Dual Action?

A: It provides fast, long-lasting pain relief, requires lower maximum daily doses of each medication, and has a favorable safety profile.

Q: Is Advil Dual Action safe?

A: Yes, clinical trials have shown that Advil Dual Action has a favorable safety profile, with no serious adverse events reported.

Q: Can I take Advil Dual Action with other medications that contain acetaminophen?

A: No, patients should not take Advil Dual Action with other medicines that also contain acetaminophen to avoid overdose and potential liver harm[4].

Sources

1. FDA approves GSK's Advil Dual Action with Acetaminophen for over-the-counter use in the United States - GSK Press Release
2. New Advil Dual Action with Acetaminophen - BioSpace
3. FDA approves GSK's Advil Dual Action with Acetaminophen for over-the-counter use in the United States - PR Newswire
4. Advil® DUAL ACTION with Acetaminophen - Haleon Health Partner
5. 211733Orig1s000 - accessdata.fda.gov - FDA Clinical Review Memorandum