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pharmafile | November 10, 2008 | News story | Research and Development, Sales and Marketing |Â Â HRTÂ
Is there an alternative to HRT for menopausal relief?
Sales of hormone replacement therapy have declined recently due to safety concerns, giving non-hormonal drugs for menopausal symptoms an estimated revenue potential of over $535 million across the US and five major EU markets in 2007. However, as current developmental drugs do not reduce symptoms substantially, their use could be limited to the minority unable to take hormone replacement therapy.
Despite its certainty, women's experiences of the menopause differ considerably. While some women encounter few, if any, symptoms, others develop severe and distressing symptoms which significantly decrease their quality of life and lead them to seek medical treatment. Of the wide range of symptoms that women going through the menopause may experience, hot flashes and night sweats (also known as vasomotor symptoms) are the most common, affecting approximately 75% of women aged over 50 years. Such symptoms can cause extreme anxiety for sufferers in work or social situations.
Although a large proportion of women experience symptoms of the menopause, not all will seek treatment. On the basis of a large, US-based study reporting that approximately 60% of symptomatic women consult a healthcare provider for help with their symptoms, Datamonitor estimates that over 68 million women will seek treatment for menopausal symptoms in the seven major markets in 2008. A number of factors could prevent a woman from receiving drug treatment, including symptoms not being severe enough to impact on quality of life and prompt treatment-seeking behavior; a physician's decision that symptoms are not severe enough to warrant treatment; a lack of patient knowledge regarding the available drug treatments, as well as patients' reluctance to interfere with what they consider to be a natural process.
HRT increases levels of the female hormones oestrogen and progestogen, which the ovaries gradually stop producing as a woman enters the menopause. Available treatment options include estrogen only, and estrogen and progestogen combination therapies.
HRT has formed the mainstay of treatment for menopausal symptoms for almost 60 years. Such treatments are highly effective and have been reported to reduce hot flashes and their frequency in postmenopausal women by 70-90%. However, since 2002, large studies have generated much controversy and concern over the safety of HRT. Arguably the most influential of these was the Women's Health Initiative (WHI) trials, which linked use of HRT to an increased risk of breast cancer and certain cardiovascular diseases.
The publication of this and similar studies substantially reduced physician and patient confidence in HRT and led to high rates of treatment discontinuation. As a result, sales of HRT products fell sharply and demand increased for safe and effective non-hormonal treatment options. Key opinion leaders interviewed by Datamonitor agree that six years after the initial publication of the WHI trial data, alarm raised by media reporting continues to generate mistrust of HRT for menopausal symptoms among patients.
However, new research published this month in the European Heart Journal may go some way toward allaying this recent mistrust. The research claims that women who take HRT to treat menopause symptoms do not have a higher than usual risk of heart attack, especially if they use a cream or skin patch. The observational study of over 698,098 healthy Danish women aged 51-69 represents the latest in the ongoing debate over the safety of HRT and suggests that large, widely publicised studies linking HRT use to cardiovascular events and breast cancer may not be the last word on treatment.
Nevertheless, non-hormonals certainly offer potential in the treatment of menopausal symptoms. The key opportunity for non-hormonal treatment lies in capturing sales that have been lost by the hormonal treatments since 2002. On this basis, Datamonitor estimates non-hormonal treatments to have revenue potential of at least $535 million across the US and 5EU markets in 2007. In order to be widely prescribed, the ideal non-hormonal treatment for symptoms of the menopause must possess comparable efficacy to HRT, minimal side effects, and be able to be safely co-administered with commonly prescribed drugs. Crucially, such a drug must carry no increased risk of breast cancer or cardiovascular problems.
Despite increased interest in non-hormonal treatment options since the 2002 publication of the WHI trial data, there are only four non-hormonal drugs presently in development for the treatment of menopausal symptoms, compared to the 12 hormonal treatments in development. The current non-hormonal pipeline is dominated by reformulations of centrally acting drugs, principally antidepressants, which have historically been the most extensively studied pharmacological alternatives to HRT. The remainder of the non-hormonal pipeline comprises a reformulation of a marketed anticonvulsant drug. Although regulatory approval of antidepressants for menopausal symptoms may represent a benefit to the estimated 25% of women undergoing the menopausal transition who experience depressive symptoms, Datamonitor believes that their dominance renders the non-hormonal development pipeline weak and lacking in innovation.
Available clinical trial data demonstrate that, as well as being few in number, developmental non-hormonal drugs do not match the effectiveness of conventional hormonal treatments in reducing hot flashes and night sweats. For example, at 12 weeks, 100mg of Wyeth's Pristiq (desvenlafaxine) has been found to reduce hot flashes by 64%. By comparison, the market leading hormonal treatment-Premarin (conjugated equine estrogen-CEE), which is also marketed by Wyeth, reduces the frequency of hot flashes by 94% at 12 weeks. Although it is presently experiencing regulatory delays, Datamonitor believes that Pristiq could by the first non-hormonal treatment to enter the menopause market in early 2009. Key advantages of Pristiq include its rapid onset of action and ability to improve sleep quality and mood while not negatively effecting sexual function.
At first glance, the future for non-hormonals appears bleak, with future sales revenue unlikely to rival that of HRT products, which generated combined sales of $1.57 billion. Nevertheless, Datamonitor believes that they will be welcomed as useful additional treatment options by doctors for the estimated 115 million women in the seven major markets who are eligible for drug intervention for their troublesome menopausal symptoms.
In particular, it is expected that demand for a safe non-hormonal treatment for symptoms of the menopause will be high among key patient groups for whom HRT is not a suitable treatment option. These core groups include breast cancer patients and survivors of breast cancer, as well as women with certain cardiovascular disorders.
Furthermore, highly symptomatic women who do not wish to receive HRT due to profound safety concerns, and mildly symptomatic women who do not believe their symptoms are severe enough to warrant HRT use, also represent potential patients for companies developing non-hormonal treatments for menopausal symptoms.
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