Boehringer to switch Flomax from POM to P
pharmafile | December 3, 2008 | News story | Sales and Marketing |Â Â OTCÂ
Boehringer Ingelheim's consumer arm has applied to make its urological disorder drug Flomax (tamsulosin) available in the UK from pharmacists without a prescription.
If the proposed 'POM to P' switch is approved by the MHRA, Boehringer Ingelheim Consumer Healthcare will market tamsulosin under the brand name Flomax Relief from next year as a once-daily 400-mcg tablet.
Boehringer's marketing director for consumer healthcare Anna Maxwell said the move was "designed to support the appropriate management of BPH which, in turn, will help to draw more men into the healthcare system".
There will be training for pharmacists and a screening questionnaire for them to identify which patients should receive Flomax Relief.
There are concerns that the availability of a non-prescription product could lead to a missed or delayed diagnosis of more serious conditions such as prostate or bladder cancer.
But Boehringer counters these by saying that early prostate cancer has no particular symptoms and is no more common in men with LUTS than in the general male population of similar age.
It also argues that clinical examination will come after a maximum of ten weeks' treatment with Flomax Relief since pack sizes are 14 or 28 capsules.
As part of the manufacturer's proposed communications programme to support the switch, healthcare specialist PR agency Virgo Health will help raise awareness of BPH as a common and treatable condition.
Tamsulosin is an alpha1-blocker prescribed to treat lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
It will continue to be available in the UK – as at present – as a prescription-only medicine (POM) marketed by Astellas Pharma as Flomaxtra XL (tamsulosin hydrochloride).
One in four men over the age of 40 is reported to be affected by the condition, also known as an enlarged prostate.
Sufferers commonly have to get up several times a night to urinate or have difficulty starting to urinate.
Tamsulosin relaxes the muscles in the prostate and urethra, and lets urine pass more readily through the urethra.
Flomax Relief would only be available to men over the age of 45.
Boehringer argues switching the product's prescription status so it available directly from pharmacies will offer greater convenience for patients, and increase the number of men treating LUTS.
In the UK there are now an estimated 2.5 million men with "symptomatic" BPH, only 6% of whom seek medical advice.
A low level of awareness by men that something can be done, embarrassment, and acceptance of symptoms as part of the ageing process are seen as the main reasons for this.
Boehringer's sales of Flomax rose 7.3% year on year to 496 million euros in the first half of 2008.
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