CLINICAL TRIALS PROFILE FOR MEGACE ES

All Clinical Trials for Megace Es

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002345 ↗	The Safety and Effectiveness of Megace in HIV-Infected Women	Completed	Bristol-Myers Squibb	Phase 4	1969-12-31	To further evaluate the safety of megestrol acetate (Megace) oral suspension in the treatment of anorexia and cachexia in HIV-positive women. To compare the effectiveness of 2 doses of Megace by measurement of weight gain, appetite grade, and other parameters at 12 and 24 weeks.
NCT00031707 ↗	Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite	Completed	National Cancer Institute (NCI)	Phase 3	2000-03-01	RATIONALE: Megestrol and /or an omega-3 fatty acid-enriched nutritional supplement may improve cancer-related weight loss and lack of appetite. It is not yet known whether megestrol alone, an omega-3 fatty acid-enriched nutritional supplement alone, or a combination of both is most effective in treating cancer-related weight loss and loss of appetite. PURPOSE: Randomized phase III trial to compare the effectiveness of megestrol with or without an omega-3 fatty acid-enriched nutritional supplement to that of the omega-3 fatty acid-enriched nutritional supplement alone in treating patients who have cancer-related weight loss and lack of appetite.
NCT00031707 ↗	Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite	Completed	NCIC Clinical Trials Group	Phase 3	2000-03-01	RATIONALE: Megestrol and /or an omega-3 fatty acid-enriched nutritional supplement may improve cancer-related weight loss and lack of appetite. It is not yet known whether megestrol alone, an omega-3 fatty acid-enriched nutritional supplement alone, or a combination of both is most effective in treating cancer-related weight loss and loss of appetite. PURPOSE: Randomized phase III trial to compare the effectiveness of megestrol with or without an omega-3 fatty acid-enriched nutritional supplement to that of the omega-3 fatty acid-enriched nutritional supplement alone in treating patients who have cancer-related weight loss and lack of appetite.
NCT00031707 ↗	Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite	Completed	Alliance for Clinical Trials in Oncology	Phase 3	2000-03-01	RATIONALE: Megestrol and /or an omega-3 fatty acid-enriched nutritional supplement may improve cancer-related weight loss and lack of appetite. It is not yet known whether megestrol alone, an omega-3 fatty acid-enriched nutritional supplement alone, or a combination of both is most effective in treating cancer-related weight loss and loss of appetite. PURPOSE: Randomized phase III trial to compare the effectiveness of megestrol with or without an omega-3 fatty acid-enriched nutritional supplement to that of the omega-3 fatty acid-enriched nutritional supplement alone in treating patients who have cancer-related weight loss and lack of appetite.

Clinical Trial Conditions for Megace Es

Condition Name

Condition Name for Megace Es
Intervention	Trials
Cachexia	6
Anorexia	6
Atypical Endometrial Hyperplasia	5
Endometrial Carcinoma	4

Condition MeSH

Condition MeSH for Megace Es
Intervention	Trials
Endometrial Neoplasms	9
Hyperplasia	8
Endometrial Hyperplasia	7
Cachexia	6

Clinical Trial Locations for Megace Es

Trials by Country

Trials by Country for Megace Es
Location	Trials
United States	112
Canada	12
South Africa	5
Korea, Republic of	4
China	3

Trials by US State

Trials by US State for Megace Es
Location	Trials
California	7
North Carolina	6
Pennsylvania	6
Missouri	5
Ohio	5

Clinical Trial Progress for Megace Es

Clinical Trial Phase

Clinical Trial Phase for Megace Es
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	3
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Megace Es
Clinical Trial Phase	Trials
Completed	19
Recruiting	5
Withdrawn	4

Clinical Trial Sponsors for Megace Es

Sponsor Name

Sponsor Name for Megace Es
Sponsor	Trials
National Cancer Institute (NCI)	10
Asan Medical Center	4
Fudan University	2

Sponsor Type

Sponsor Type for Megace Es
Sponsor	Trials
Other	46
Industry	13
NIH	10

Megace ES: Clinical Trials, Market Analysis, and Projections

Introduction to Megace ES

Megace ES, an oral suspension formulation of megestrol acetate, is a progestin indicated for the treatment of anorexia, cachexia, or unexplained significant weight loss in patients with acquired immunodeficiency syndrome (AIDS)[1][2][5].

Clinical Trials and Efficacy

Clinical Trial Outcomes

The efficacy of Megace ES was established through several clinical trials. These trials demonstrated that Megace ES is effective in increasing appetite, caloric intake, and weight in patients with AIDS-related anorexia and cachexia.

• In one trial, patients receiving Megace ES showed a significant increase in mean weight by 13.3 pounds, with improvements in lean body mass and fat body mass. Additionally, there was an increase in mean caloric intake by 464 calories per day, and seven out of ten patients experienced improved appetite[2].
• Another study highlighted that patients treated with Megace ES reported an improved sense of well-being, which is a critical aspect of quality of life for patients suffering from chronic diseases[2].

Pharmacokinetics and Bioavailability

Pharmacokinetic studies have shown that Megace ES has improved bioavailability compared to the original formulation. When administered under fasting and fed conditions, the pharmacokinetics of megestrol acetate were linear in the dosing range between 150 mg and 675 mg. The mean peak plasma concentration (Cmax) and the mean area under the concentration time-curve (AUC) were increased by 48% and 36%, respectively, after a high fat meal, but this effect was less pronounced than in the original formulation[1][4].

Safety Profile

The safety profile of Megace ES was evaluated in several studies, which identified common adverse reactions such as diarrhea, nausea, vomiting, and flatulence. However, these reactions were generally manageable and did not significantly impact the overall safety of the drug. There is also a consideration for adrenal insufficiency in patients receiving or being withdrawn from chronic Megace ES therapy, emphasizing the need for monitoring and potential glucocorticoid replacement[1][4].

Market Analysis

Current Market Status

The global appetite stimulant market, dominated by the megestrol acetate segment, is expected to grow significantly. Megace ES, as a key product in this segment, benefits from the increasing demand for appetite-restoring medications driven by the rising prevalence of chronic diseases such as cancer, AIDS, and other conditions[3][5].

Market Size and Growth Projections

• The global appetite stimulant market is projected to grow from USD 1.7 billion in 2022 to USD 3.1 billion by 2032, at a CAGR of 6.2%[3].
• The megestrol acetate segment, which includes Megace ES, is anticipated to experience the fastest growth due to its efficacy in treating anorexia and cachexia associated with chronic diseases[3].

Regional Outlook

The global megestrol market is segmented geographically, with North America, Europe, Asia-Pacific, and the rest of the world being key regions. Emerging economies such as India, China, and several African nations are driving the growth due to their rapid economic expansion and enhanced healthcare infrastructure[5].

Competitive Landscape

Megace ES, developed by Par Pharmaceutical using Elan's NanoCrystal® Technology, offers several advantages over the original formulation, including reduced volume per dose, lower viscosity, and improved bioavailability. These features enhance patient adherence and overall treatment efficacy, positioning Megace ES as a leading product in the appetite stimulant market[2].

Market Projections

Future Demand

The demand for Megace ES is expected to increase significantly due to several factors:

• Rising Prevalence of Chronic Diseases: The increasing number of patients suffering from cancer, AIDS, and other chronic diseases drives the demand for appetite-stimulating medications like Megace ES[3][5].
• Economic Development: Emerging economies with improving healthcare infrastructure are contributing to the growing demand for megestrol acetate products[3][5].
• Advancements in Formulation: The advanced formulation of Megace ES, which offers improved bioavailability and reduced volume per dose, enhances patient compliance and treatment outcomes, further boosting its market potential[2].

Market Trends

• Increased Focus on Quality of Life: There is a growing emphasis on improving the quality of life for patients with chronic diseases, which includes managing symptoms like anorexia and cachexia effectively. Megace ES aligns with this trend by providing a effective treatment option[2].
• Technological Innovations: The use of advanced technologies like NanoCrystal® Technology in the formulation of Megace ES is expected to continue driving innovation in the appetite stimulant market[2].

Key Takeaways

• Clinical Efficacy: Megace ES has been shown to be effective in increasing appetite, caloric intake, and weight in patients with AIDS-related anorexia and cachexia.
• Improved Bioavailability: The new formulation offers better bioavailability and can be taken without regard to meals, enhancing patient compliance.
• Market Growth: The global appetite stimulant market, driven by the megestrol acetate segment, is expected to grow significantly, with emerging economies playing a crucial role.
• Competitive Advantage: Megace ES's advanced formulation and reduced volume per dose position it as a leading product in the market.

FAQs

What is Megace ES used for?

Megace ES is used for the treatment of anorexia, cachexia, or unexplained significant weight loss in patients with acquired immunodeficiency syndrome (AIDS)[1][2][5].

How does Megace ES differ from the original formulation?

Megace ES has a reduced volume per dose, lower viscosity, and improved bioavailability compared to the original megestrol acetate oral suspension. It can be taken without regard to meals[2].

What are the common adverse reactions associated with Megace ES?

Common adverse reactions include diarrhea, nausea, vomiting, and flatulence. There is also a risk of adrenal insufficiency in patients receiving or being withdrawn from chronic therapy[1][4].

What is the projected market growth for the appetite stimulant market?

The global appetite stimulant market is expected to grow from USD 1.7 billion in 2022 to USD 3.1 billion by 2032, at a CAGR of 6.2%[3].

Why is the demand for Megace ES increasing?

The demand is increasing due to the rising prevalence of chronic diseases, economic development in emerging economies, and the advanced formulation of Megace ES which enhances patient compliance and treatment outcomes[3][5].

Sources

1. Drugs.com: Megace ES: Package Insert / Prescribing Information.
2. NATAP: FDA Approves Megace ES for Anorexia, Cachexia, or Unexplained, Significant Weight Loss in Patients With AIDS.
3. MarketResearch.biz: Appetite Stimulant Market Size, Share, Trends | Forecast 2032.
4. FDA: Megace® ES (megestrol acetate, USP) Oral Suspension.
5. OMR Global: Megestrol Market Size, Share, Trends, Industry Report and Forecast.