‘FLOMAXTRA XL’ LAUNCHED TODAY – NEW TREATMENT OPTION FOR BENIGN PROSTATIC HYPERPLASIA (BPH) BRINGS PATIENT BENEFITS THROUGH IMPROVED QUALITY OF LIFE OUTCOMES Two million patients with BPH in UK could benefit from new treatment advance
1st September 2005: Astellas Pharma Ltd announced today the UK approval and launch of ‘Flomaxtra XL’ 400 mcg for the treatment of the functional symptoms of benign prostatic hyperplasia (BPH), which could allow health care professionals (HCPs) to manage the condition more effectively. ‘Flomaxtra XL’ is an improved formulation of the BPH drug tamsulosin (‘Flomax MR’), using a patented and innovative new delivery system – OCAS (Oral Controlled Absorption System).
OCAS, developed by Astellas, delivers a more consistent release of tamsulosin over 24 hours with a reduced peak plasma concentration and a smoother pharmacokinetic profile.(1) A key patient benefit of this consistent 24 hour delivery is the potential for ‘Flomaxtra XL’ to significantly reduce one of the most bothersome symptoms of BPH; night-time disturbance caused by the need for urination. (2) This symptom, known as nocturia, has a major impact on patient and partner well-being. (3 )
Dr Mark Speakman, Consultant Urologist, Taunton Hospital, expanded further on the important implications of the new formulation ‘Flomaxtra XL’: “Whilst we should remember that for many years Flomax has been and still is a highly effective, top level treatment in this area, Flomaxtra XL potentially brings even greater benefit. In addition to the improvement in nocturia, the smoother 24 hour release of the drug has very encouraging implications in terms of side-effect profile in comparison with existing therapies.’’
Data for ‘Flomaxtra XL’ have shown a lower incidence of cardiovascular (CV) side-effects in comparison with conventional tamsulosin, with a smaller effect on blood pressure, minimal heart rate increases and fewer orthostatic episodes.(4 ) ‘Flomaxtra XL’ is easy to administer with a once daily tablet to be taken with or without food at any consistent time of the day – in contrast to existing therapies which often have to be taken at a set time each day, or after food, making adherence more difficult.
A recent NOP survey involving over 200 GPs in the UK, revealed that 93% of their patients reported nocturia as one of the three most bothersome symptoms of BPH,5 with frequency and urgency of urination being the other most common. Furthermore 68% of GPs ranked nocturia as the most bothersome symptom and considered that 97% of patients complained that night-time wakening was detrimental to their quality of life.( 5) In addition 95% of GPs said that they were very or fairly likely to use a new therapy for BPH if it was shown to improve the symptoms of BPH and in turn improve patients’ quality of life. 5 In terms of the patient benefit that such a new therapy would need to offer GPs ranked improvement in nocturia, a lower incidence of CV side effects and ease of administration as the main attributes needed. (5)
Astellas is introducing ‘Flomaxtra XL’ as a 30 tablet pack, at a price of £17.55. This represents a 15% discount on the current MR version of tamsulosin, ‘Flomax’. Today’s launch of ‘Flomaxtra XL’ will enable GPs to consider both patients already taking tamsulosin and new patients for treatment with this important therapeutic advance that provides good symptom relief and a significant improvement in side-effects.
Benign Prostatic Hyperplasia in the UK BPH is estimated to affect around one in five men aged between 50 and 59 and this rises to one in three at 60 years plus.(6) Only a minority of men with BPH are actually diagnosed as having the condition, leaving the majority undiagnosed, in fact approximately 45% of BPH patients suffer their symptoms for one year before consulting their doctor.(6) BPH significantly impacts the quality of life of those suffering from the condition; it has been associated with depression, anxiety, sexual dysfunction, difficulty in carrying out work or daily activities and sleeping problems – disturbing both their own, and their partners’ lives.(8,9,3) It is important that men and their partners recognise BPH symptoms and seek medical advice. With the many treatments available to treat BPH, men should not suffer in silence or wrongly believe urinary problems are an inevitable part of the ageing process.
In current clinical practice the two types of medical treatment that are used to control and alleviate the symptoms of BPH are alpha blockers which relax the muscle in the prostate and relieve pressure on the urethra and 5-alpha reductase inhibitors which reduce dihydrotesterone (DHT) levels and so shrink enlarged prostate glands. Alpha blockers such as tamulosin are often the first-line treatment for BPH, offering patients effective symptomatic control with a favourable tolerability profile.
Commenting on the need for patients to be aware of the symptoms of BPH and the therapeutic options available, Dr Mark Speakman, Consultant Urologist, Taunton Hospital added “BPH is a very common and manageable disease yet we know many men feel embarrassed to discuss their symptoms with their doctor, often suffering in silence unnecessarily. New developments such as the launch today of Flomaxtra XL are important, but we must also do more to help men, and their partners, recognise their symptoms and encourage them to go to their GP to seek medical advice.”
References: 1. Michel MC, Korstanje C, Krauwinkel W, et al. The pharmacokinetic profile of tamsulosin oral controlled absorption system (OCAS). European Urology Supplements 4 (2005) 15-24 2. Data on file TOC 01. Astellas Pharma Ltd 3. Schulman CC, Asplund R, Desgrandchamps F, et al. The impact of nocturia on health status and quality of life in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH). European Urology Supplements 4 (2005) 1-8 4. Michel MC, Korstanje C, Krauwinkel W, et al. Cardiovascular safety of the oral controlled absorption system (OCAS) formulation of tamsulosin compared to the modified release (MR) formulation. European Urology Supplements 4 (2005) 53-60 5. NOP Survey-The Online Quota Based GP Omnibus Service-Benign Prostatic Hyperplasia, August 2005 6. ‘Looking After Your Man’. Yamanouchi patient leaflet. September 2003 7. Audience Selection survey. ‘Men’s Health: Survey on Urinary Problems’. August 2000 8. Welch G, et al. Quality-of-life impact of lower urinary tract symptom severity: results from health professionals follow-up study. Urology. 2002 59: 245-250 9. Rosen R, Altwein J, et al. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). European Journal of Urology. December 2003 44(6):637-49
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