Stakeholder Opinions: Non-hormonal Treatments for Menopausal Symptoms - Market open to takers as tepid pipeline fails to meet demand

Published by: Datamonitor

Published: Jun. 17, 2008 - 135 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the Urology and Gender-specific Health pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Market definition for this report

Objective of the analysis

Strategic scoping and focus

Datamonitor insight into the non-hormonal menopause market

Contributing experts

Related reports

CHAPTER 2 PATIENT POTENTIAL

Condition definition

Symptoms of the menopause

Pathogenesis of vasomotor symptoms has not yet been fully elucidated

Vasomotor symptoms affect 75% of women over the age of 50

Prevalence of vasomotor symptoms is associated with changes in menopausal status

There exist ethnic and cultural variations in the prevalence of menopausal symptoms

Menopausal symptoms negatively impact quality of life

Patient presentation and diagnosis

Approximately 60% of symptomatic women seek help with menopausal symptoms

Companies developing non-hormonal treatments would benefit from targeting mildly symptomatic patients

Diagnosis of menopause is usually made by menstrual and medical history

Identifying the target population

The average age of onset of natural menopause is 51 years

Genetics and cigarette smoking can influence the timing of natural menopause

Over 166 million women in the seven major markets are peri- or post-menopausal

Approximately 115 million women in the seven major markets will experience menopausal symptoms

Over 68 million women will seek treatment for menopausal symptoms in the seven major markets in 2008

The target patient population will grow by 34% by 2050 in the seven major markets

The proportion of postmenopausal women living in developing nations is set to grow

Women aged 45-55 are not the only patients to experience menopausal symptoms

Premature ovarian failure occurs in women younger than age 40

Premature ovarian failure affects over 1 million women in the seven major markets

Surgically induced and medical menopause

Breast cancer patients and survivors experience hot flashes

CHAPTER 3 CURRENT MARKET SITUATION AND FUTURE POTENTIAL

Current treatment options

Hormonal therapies are the mainstay of treatment for symptoms of the menopause

Complementary and alternative medicine: popular yet lacking in long-term data

Efficacy studies of complementary and alternative medicines are inconsistent and inconclusive

Professional organizations provide contrasting recommendations regarding use of herbal treatments

Non-hormonal treatments are presently prescribed off-label

CNS drugs are the most widely prescribed off-label treatments

Treatment guidelines acknowledge that non-hormonal alternatives show promise

The rationale for a non-hormonal approach to treatment

Patients and physicians will welcome non-hormonal menopause treatments

Women's Health Initiative identified important risk factors associated with the use of HRT

Breast cancer patients and survivors require non-hormonal treatment options due to contraindication of HRT

Patients with cardiovascular disorders are also a target population for non-hormonal treatments

Market potential of non-hormonal treatments for menopausal symptoms

Non-hormonal treatments have the potential to capture at least $535m across the US and 5EU

Nevertheless, HRT will remain the mainstay of treatment

Prescriber confidence with HRT is slowly returning

Patients' ongoing mistrust of HRT represents a market opportunity for non-hormonal treatments

CHAPTER 4 R&D PIPELINE OVERVIEW AND CLINICAL TRIAL DESIGN

Introduction

Historically, antidepressants have been investigated as potential treatments

The ideal non-hormonal treatment of menopausal symptoms

Pipeline overview

Small pipeline consists exclusively of reformulated centrally acting drugs

Non-hormonal pipeline is of a comparable size to the HRT pipeline

Interest continues in serotonergic mechanisms

Wyeth: endeavoring to maintain share of the menopause market

Future potential of pipeline non-hormonal treatments for menopausal symptoms

Efficacy does not match that of conventional hormonal therapies

However, regulatory approval will increase acceptance and prescriber confidence

Targeting of co-morbid conditions offers benefit to patients

Safety concerns surrounding use of non-hormonals for menopausal symptoms must be addressed

Physicians concerns over the long-term safety of antidepressant use in non-depressed women need to be allayed

Treatment considerations for breast cancer patients and survivors

Stigma surrounding use of antidepressants for a non-psychiatric indication

Serotonergic drugs

Pristiq (desvenlafaxine)

Drug overview

Pristiq is set to be the first non-hormonal treatment approved for menopausal symptoms

Generic Effexor is unlikely to limit uptake of Pristiq for menopausal symptoms

Pristiq - strengths and weaknesses

Clinical trial data

Org-50081 (esmirtazapine maleate)

Drug overview

Phase III clinical trial design

Datamonitor comments

CPT-347

Drug overview

Datamonitor comments

Anticonvulsants

Gabapentin GR/Xenolev CR

Drug overview

Guidelines already recognize gabapentin as an alternative to HRT

Reported comparable efficacy between gabapentin and estrogen

Gabapentin may be of particular benefit to breast cancer patients

Gabapentin GR/Xenolev CR - strengths and weaknesses

Clinical trial data

Recently discontinued pipeline products

Keppra (levetiracetam, injectable)

Clinical trial design in non-hormonal treatment research

Inclusion and exclusion criteria

Primary and secondary endpoints

Principal primary endpoint: patient-reported hot flash frequency and severity

Secondary endpoint measures

Key challenges in menopausal symptom clinical trials

Interventions for menopausal symptoms elicit a high placebo response

Subjective versus objective measures of vasomotor symptoms

BIBLIOGRAPHY

Journal papers

Websites

Datamonitor reports

APPENDIX

Contributing experts

Report methodology

Market sizing caveats

ATC classes

ICD-10 codes

Data definitions, limitations and assumptions

Standard Units

HRT for menopause specific sales calculations

About Datamonitor

About Datamonitor Healthcare

About the Gender-specific Health analysis team

Disclaimer

List of Tables

Table 1: Prevalence of menopausal symptoms in women aged 40-54 in the 7MM, 2008

Table 2: Frequency of menopausal symptoms in a sample of women aged 40-55 years old, by menopausal transition phase

Table 3: The potential treatable population for menopausal symptoms across the seven major markets, 2008

Table 4: Number of women who experience menopausal symptoms in the menopausal transition period in the seven major markets, 2008

Table 5: Number of women seeking treatment for menopausal symptoms in the seven major markets, 2008

Table 6: Number of women with premature ovarian failure in the seven major markets , 2008

Table 7: Crude female invasive breast cancer incidence rates (per 100,000 persons) in the seven major markets, 2002

Table 8: Forecast incidence of invasive female breast cancer in the seven major markets, 2002-17

Table 9: Key trials of antidepressant drugs for menopausal symptoms, 2008

Table 10: Non-hormonal drugs in development for the treatment of menopausal symptoms, 2008

Table 11: Organon/Schering Plough's marketed gynecology and fertility products, 2008

Table 12: Primary efficacy outcomes of Gabapentin GR Phase II study

List of Figures

Figure 1: Model of the pathogenesis of hot flashes

Figure 2: Healthcare seeking behavior for menopausal symptoms

Figure 3: Number of women in the menopausal symptoms treatment pathway in the seven major markets, 2008

Figure 4: Projection of the female population over 45 years old across the seven major markets, 2005-2050

Figure 5: Market share and growth of total off-label non-hormonal prescription market across the seven major markets, 2006-07

Figure 6: Sales revenue of key non-hormonal brands prescribed off-label for menopausal symptoms, 2007

Figure 7: Timeline of key studies affecting the HRT market

Figure 8: Event rates in the Women's Health Initiative study

Figure 9: Value of the HRT for menopausal symptoms market in the 6MM, 1999-2007

Figure 10: Estimated revenue potential of non-hormonal treatments in the US and 5EU combined, 2007

Figure 11: Drugs in the HRT and non-hormonal development pipeline by stage, 2008

Figure 12: Comparison of efficacy data of key pipeline drugs and Premarin for vasomotor menopausal symptoms

Figure 13: Pristiq: strengths and weaknesses for menopausal symptoms, 2008

Figure 14: Gabapentin GR: strengths and weaknesses for menopausal symptoms, 2008

Abstract

• Overview of menopause, including a review of the prevalence of vasomotor symptoms to better understand the size of the target patient population.
• Summary of topical issues in the treatment of menopausal symptoms and rationale for a non-hormonal approach treatment.
• Review of pipeline non-hormonal drugs and analysis of their future potential in relation to currently available hormone replacement therapy.
• Insight from interviews with seven key international experts in the field of menopause and associated treatments

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