Boehringer Ingelheim’s prostate enlargement drug Flomax Relief MR and Cyklo for heavy menstrual bleeding are now available through pharmacists following their approval as over-the-counter medicines.

Tamsulosin hydrochloride, the active ingredient in Flomax, has actually been available as a prescription for benign prostatic hyperplasia for more than a decade, but despite this, and the fact that the condition affects an estimated one in four men over the age of 40, public awareness of the condition and its symptoms is low.

According to Boehringer, results of a recent survey revealed that not only had an astonishing 59% of men failed to visit a healthcare professional even though 87% had been suffering from BPH for between six months to over two years, but that 92% were not aware of therapies that could help to relieve the symptoms.

The survey’s findings indicate that there is a substantial degree of unrealised potential in the BPH market in the UK, and the German drugmaker said it is hoping that, backed by a high profile publicity campaign, Flomax’ switch to OTC will help raise awareness among men and “encourage patient enquiries about this common but little-known condition”.

Furthermore, as the supply model requires that patients given the therapy by pharmacists visit their GP during the first six weeks of treatment for a BPH diagnosis, followed by subsequent annual prostate checks, the OTC availability of the drug is also expected to increase GP screening opportunities with men, who can be difficult to reach particularly when health complaints relate to ‘sensitive’ issues.

“We hope that the availability of this product in pharmacy will encourage men with urinary symptoms to seek advice and support from a healthcare professional, thereby improving their quality of life,” said Kate Evans, Senior Brand Manager for Flomax Relief at BI.

“Pharmacists are ideally placed to compliment the role of GP’s and other health providers by both treating symptoms of benign prostatic hyperplasia and crucially picking up the signs of more serious illness early – improving the chance of a good outcome,” commented Graham Phillips, pharmacist, and Royal Pharmaceutical Society English Pharmacy Board Member.

Cyklo-F goes OTC
Meanwhile, the Medicines and Healthcare products Regulatory Agency has also approved OTC status for Meda Pharmaceuticals’ Cyklo-F (tranexamic acid) for the treatment heavy menstrual bleeding in women.

Cyklo-F has been on the market for more than 40 years and is used by millions of women around the globe. Every year in the UK around one in 20 women aged between 30-49 years consults a GP or healthcare professional with heavy menstrual bleeding, but now they will be able to get treatment from a pharmacist without the need for a doctor’s prescription.

According to MHRA Director of Vigilance and Risk Management of Medicines June Raine, the move is an “important step” for women that will allow them to successfully take charge of this condition, and she reiterated the Agency’s commitment to “improving access to over-the-counter medicines for self care where it is safe to do so, providing greater choice and access for the public”.