CLINICAL TRIALS PROFILE FOR FLAGYL ER

505(b)(2) Clinical Trials for FLAGYL ER

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
New Formulation	NCT01559545 ↗	A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis	Completed	Reliance Clinical Research Services (Navi Mumbai, India)	Phase 2	2012-03-01	Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly in people who have taken potent antibiotics. When C. difficile multiplies within the colon, it produces two toxins that cause inflammation and resultant abdominal pain, fever and diarrhea. Current treatment of mild to moderate disease is with immediate release metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed a delayed release form of metronidazole to release just before the colon to increase the concentration of antibiotic in the colon to improve the effectiveness of metronidazole treatment and potentially to allow less whole body exposure to the antibiotic. This study will measure the amount of metronidazole in the blood and stool of patients with C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing the antibiotic as designed, immediately before the colon.
New Formulation	NCT01559545 ↗	A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis	Completed	Dr. Reddy's Laboratories Limited	Phase 2	2012-03-01	Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly in people who have taken potent antibiotics. When C. difficile multiplies within the colon, it produces two toxins that cause inflammation and resultant abdominal pain, fever and diarrhea. Current treatment of mild to moderate disease is with immediate release metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed a delayed release form of metronidazole to release just before the colon to increase the concentration of antibiotic in the colon to improve the effectiveness of metronidazole treatment and potentially to allow less whole body exposure to the antibiotic. This study will measure the amount of metronidazole in the blood and stool of patients with C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing the antibiotic as designed, immediately before the colon.

All Clinical Trials for FLAGYL ER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00257699 ↗	Study of Antibiotics in the Treatment of Colonic Crohn's Disease	Terminated	Crohn's and Colitis Foundation	Phase 2	2006-05-01	Crohn's disease (CD) is a form of inflammatory bowel disease that can affect any part of the digestive system. Symptoms of this chronic illness include abdominal pain, bloating, nausea, vomiting, and diarrhea. CD also causes bowel wall ulcers, strictures (narrowings of a hollow structure due to scar tissue and swelling), and fistulae (abnormal passages from the intestines to another organ or to the skin). CD is thought to arise from a combination of inherited (genetic) factors and some undefined environmental factor(s). One environmental factor that has been shown to be intimately involved with the development of CD is the presence of bacteria that normally inhabit the intestines. As a result, some physicians have tried to alter the normal bacterial population as a means of controlling the inflammation (swelling) in the intestines of individuals with CD. Among such strategies is the use of a combination of metronidazole and ciprofloxacin. These broad-spectrum antibiotics control CD symptoms by acting on the intestinal bacteria that can contribute to chronic inflammation. More investigation is needed to firmly establish the usefulness of this therapy because previous clinical trials have given mixed results, although they have suggested that antibiotics can be particularly useful in cases of Crohn's colitis (CD that primarily affects the large intestine). Because these earlier studies have lacked a large enough patient population with colonic involvement, a trial focusing on this CD subgroup with a sufficient number of subjects will help to clarify the value of combining metronidazole and ciprofloxacin. The proposed study will test the hypothesis that combination antibiotic therapy is effective in the treatment of CD involving the colon. The study will compare the use of combination therapy consisting of metronidazole and ciprofloxacin with placebo (dummy tablets) and will examine the results of treatment at the end of 8 weeks of treatment.
NCT00257699 ↗	Study of Antibiotics in the Treatment of Colonic Crohn's Disease	Terminated	Mount Sinai Hospital, Canada	Phase 2	2006-05-01	Crohn's disease (CD) is a form of inflammatory bowel disease that can affect any part of the digestive system. Symptoms of this chronic illness include abdominal pain, bloating, nausea, vomiting, and diarrhea. CD also causes bowel wall ulcers, strictures (narrowings of a hollow structure due to scar tissue and swelling), and fistulae (abnormal passages from the intestines to another organ or to the skin). CD is thought to arise from a combination of inherited (genetic) factors and some undefined environmental factor(s). One environmental factor that has been shown to be intimately involved with the development of CD is the presence of bacteria that normally inhabit the intestines. As a result, some physicians have tried to alter the normal bacterial population as a means of controlling the inflammation (swelling) in the intestines of individuals with CD. Among such strategies is the use of a combination of metronidazole and ciprofloxacin. These broad-spectrum antibiotics control CD symptoms by acting on the intestinal bacteria that can contribute to chronic inflammation. More investigation is needed to firmly establish the usefulness of this therapy because previous clinical trials have given mixed results, although they have suggested that antibiotics can be particularly useful in cases of Crohn's colitis (CD that primarily affects the large intestine). Because these earlier studies have lacked a large enough patient population with colonic involvement, a trial focusing on this CD subgroup with a sufficient number of subjects will help to clarify the value of combining metronidazole and ciprofloxacin. The proposed study will test the hypothesis that combination antibiotic therapy is effective in the treatment of CD involving the colon. The study will compare the use of combination therapy consisting of metronidazole and ciprofloxacin with placebo (dummy tablets) and will examine the results of treatment at the end of 8 weeks of treatment.
NCT00353743 ↗	The Use of Antibiotics After Hospital Discharge in Septic Abortion	Terminated	Hospital de Clinicas de Porto Alegre	N/A	2006-05-01	The use of antibiotics in post-partum infection has been abbreviated. After 48 hours of clinical improvement, the patient is discharged from the hospital without antibiotics. No trials has been found in cases of septic abortion. The purpose of the present study is to verify the need of antibiotics after clinical improvement in cases of septic abortion.
NCT00195923 ↗	Prospective Randomized Evaluation of Antibiotic Regimen Following Appendectomy for Perforated Appendicitis	Completed	Children's Mercy Hospital Kansas City		2005-04-01	The purpose of this study is to compare traditional triple antibiotic therapy against dual single day dosing antibiotic therapy in the management of perforated appendicitis in children.

Clinical Trial Conditions for FLAGYL ER

Condition Name

Condition Name for FLAGYL ER
Intervention	Trials
Helicobacter Pylori Infection	11
Bacterial Vaginosis	6
Crohn's Disease	3
Inflammatory Bowel Diseases	2

Condition MeSH

Condition MeSH for FLAGYL ER
Intervention	Trials
Infections	10
Infection	10
Communicable Diseases	8
Helicobacter Infections	8

Clinical Trial Locations for FLAGYL ER

Trials by Country

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−

Trials by Country for FLAGYL ER
Location	Trials
United States	38
Taiwan	10
India	7
Brazil	6
Canada	6

Trials by US State

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−

Trials by US State for FLAGYL ER
Location	Trials
Pennsylvania	4
Michigan	3
North Carolina	3
California	3
Texas	3

Clinical Trial Progress for FLAGYL ER

Clinical Trial Phase

Clinical Trial Phase for FLAGYL ER
Clinical Trial Phase	Trials
Phase 4	26
Phase 3	10
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for FLAGYL ER
Clinical Trial Phase	Trials
Completed	36
Unknown status	15
Recruiting	10

Clinical Trial Sponsors for FLAGYL ER

Sponsor Name

Sponsor Name for FLAGYL ER
Sponsor	Trials
National Taiwan University Hospital	4
Chang Gung Memorial Hospital	4
National Institute of Allergy and Infectious Diseases (NIAID)	3

Sponsor Type

Sponsor Type for FLAGYL ER
Sponsor	Trials
Other	99
Industry	19
NIH	5

FLAGYL ER: Clinical Trials, Market Analysis, and Projections

Introduction

FLAGYL ER, an extended-release formulation of metronidazole, is a synthetic nitroimidazole antimicrobial agent used primarily in the treatment of bacterial vaginosis (BV) and other infections. This article delves into the clinical trials, market analysis, and future projections for FLAGYL ER.

Clinical Trials and Efficacy

FLAGYL ER has been extensively studied in clinical trials to assess its efficacy and safety, particularly in the treatment of bacterial vaginosis.

Bacterial Vaginosis Trials

In two randomized, multicenter, well-controlled, investigator-blind clinical trials, FLAGYL ER was compared to 2% clindamycin vaginal cream. A total of 557 non-pregnant patients with BV were randomized to receive either FLAGYL ER 750 mg once daily for 7 days or 2% clindamycin vaginal cream once daily for 7 days. The primary efficacy endpoint was clinical cure, defined as a return to normal vaginal pH, absence of a “fishy” amine odor, and absence of clue cells.

• Clinical Cure Rates: The clinical cure rates at one month post-therapy were 61% and 62% for FLAGYL ER in the two studies, compared to 59% and 43% for the clindamycin cream group. FLAGYL ER showed a statistically significant higher cure rate in one of the studies[1][2].

• Vaginal Flora Restoration: FLAGYL ER restored the normal Lactobacillus-predominant vaginal flora in a larger percentage of patients compared to the clindamycin treated group, with 74% versus 63% at one month post-therapy[1].

Adverse Events

The trials also monitored adverse events, which were generally mild or moderate. Common adverse events included headache, vaginitis, nausea, and metallic taste. These events were more frequent in the FLAGYL ER group but were mostly manageable[1][2].

Pharmacokinetics and Metabolism

Absorption and Distribution

FLAGYL ER 750 mg tablets are designed for once-daily dosing, with the extended-release formulation allowing for steady-state pharmacokinetics. The absorption rate is influenced by the presence of food, with faster absorption in the fed state compared to the fasting state[2].

Hepatic Impairment

Patients with hepatic impairment metabolize metronidazole more slowly, leading to higher plasma concentrations. FLAGYL ER should not be administered to patients with severe (Child-Pugh C) hepatic impairment unless the benefits outweigh the risks. For patients with mild to moderate hepatic impairment, no dosage adjustment is necessary, but monitoring for adverse events is recommended[1][2].

Renal Impairment

Patients with end-stage renal disease may experience accumulation of metronidazole metabolites, necessitating monitoring for associated adverse events[2].

Market Analysis

Current Market Size

The metronidazole market, which includes FLAGYL ER, was valued at USD 100 million in 2023. This market is segmented by application (tablets, capsules, injections), product process (glyoxal process, ethidene diamine process), and geographical regions[5].

Market Projections

The metronidazole market is expected to grow at a compound annual growth rate (CAGR) of 5% from 2024 to 2031, reaching USD 139.99 million by 2031. This growth is driven by increasing healthcare spending and the development of new therapies for infections such as clostridium difficile[5].

Competitive Landscape

The market for metronidazole is competitive, with several key players including Hongyuan Pharmaceutical, Unichem Laboratories, and Yinhe Aarti Pharmaceutical. Emerging therapies for clostridium difficile infection are expected to impact the market, potentially challenging the dominance of metronidazole[5].

Regulatory and Developmental Activities

Regulatory Milestones

Metronidazole has undergone various regulatory milestones, particularly in its use for clostridium difficile infection. These milestones include approvals and ongoing research activities in the United States, Europe, and Japan[3].

Research and Development

There is ongoing research into new approaches to treat clostridium difficile infection, which may influence the market share of metronidazole. Late-stage emerging therapies are expected to launch in the near future, potentially impacting the market dynamics[3].

Conclusion

FLAGYL ER has demonstrated efficacy in clinical trials for the treatment of bacterial vaginosis, with a favorable safety profile. The market for metronidazole is expected to grow, driven by increasing healthcare needs and spending. However, the emergence of new therapies for related infections may pose competition.

Key Takeaways

• Efficacy in BV: FLAGYL ER has shown significant efficacy in treating bacterial vaginosis, with higher clinical cure rates compared to some alternative treatments.
• Pharmacokinetics: The drug's extended-release formulation allows for once-daily dosing, with considerations needed for patients with hepatic or renal impairment.
• Market Growth: The metronidazole market is projected to grow at a 5% CAGR from 2024 to 2031.
• Competitive Market: The market is competitive, with emerging therapies potentially impacting metronidazole's market share.

FAQs

What is FLAGYL ER used for?

FLAGYL ER is primarily used in the treatment of bacterial vaginosis (BV) in non-pregnant women.

How is FLAGYL ER administered?

FLAGYL ER is administered orally once daily in a 750 mg extended-release tablet.

What are the common adverse events associated with FLAGYL ER?

Common adverse events include headache, vaginitis, nausea, and metallic taste.

Can FLAGYL ER be used in patients with hepatic impairment?

FLAGYL ER should not be administered to patients with severe (Child-Pugh C) hepatic impairment unless the benefits outweigh the risks. No dosage adjustment is needed for patients with mild to moderate hepatic impairment, but monitoring is recommended.

What is the projected market size for metronidazole by 2031?

The metronidazole market is expected to reach USD 139.99 million by 2031, growing at a 5% CAGR from 2024 to 2031.

References

1. FLAGYL® (metronidazole) extended-release tablets, 750 mg. FDA.
2. Flagyl ER: Package Insert / Prescribing Information. Drugs.com.
3. Metronidazole Drug Insight and Market Forecast - 2032. ResearchAndMarkets.
4. Flagyl (Metronidazole): Side Effects, Uses, Dosage. RxList.
5. Metronidazole Market Size, Trends and Projections. MarketResearchIntellect.