Keywords: Flomax, UK, OTC, Boehringer Ingelheim, USA, Ranbaxy, Generic

UK regulatory agency clears prostate drug Flomax for OTC use; generic competition due next year in USA

Article | 14 December 2009

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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has recently approved of the first over-the-counter (OTC) medicine to treat the symptoms of benign prostatic hyperplasia (BPH) in men, to be available through pharmacies without a prescription.

The drug in question, tamsulosin capsules, will be available to buy under the brand name Flomax Relief, for short-term use in men aged 45 to 75 following a consultation with a pharmacist. Tamsulosin was originated by Japan’s Yamanouchi, now part of Astellas, and is marketed by licensee Boehringer Ingelheim of Germany

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An estimated one-in-four men over the age of 40 suffer from BPH, the progressive enlargement of the prostate gland. Symptoms include urinary hesitancy, weak stream, and frequent urination, including at night.

Patients will need to obtain a GP diagnosis prior to longer-term use and annual check-ups are recommended thereafter. Flomax Relief will become available OTC in the spring of next year

MHRA director of vigilance and risk management of medicines, June Raine, said: “BPH affects millions of men in the UK every year and, while symptoms can have a significant impact on the quality of life of both the patient and their family, many men do not seek help from their doctor. Today’s move to make tamsulosin more widely available under pharmacist supervision will empower men to play a more active role in their own health care.”

Decision “not logical,” say doctors

The British Medical Association has come out against the decision, arguing that it is “not logical” because patients will still require a GP referral within weeks.

The Royal College of General Practitioners (RCGP) also slammed the switch, arguing that pharmacists “were not appropriately trained to make an accurate diagnosis of BPH” and patients “would be unlikely to speak to a pharmacist” about symptoms.

DTB readers against OTC use of the drug

Meantime, in a poll early this year, most readers surveyed by the journal Drug and Therapeutics Bulletin were not in favor of the MHRA’s plans to possibly make tamsulosin available over the counter. Readers were surveyed in December, 2008 and 251 responded. Nearly 80% did not support making tamsulosin available OTC.

Ranbaxy to debut generic Flomax in USA next March

Elsewhere, Indian generics major Ranbaxy Laboratories has said it will launch its generic version of Flomax in the USA in March 2010, allowing the Indian drug maker take advantage of its "first-to-file" status.

The "first-to-file" status - granted by the US Food and Drug Administration - gives a generic drugmaker six months of exclusive sales for their copycat versions of a medicine, helping it rake in profits before competitors launch their generic version and push prices down.

The Indian company’s USA subsidiary Impax Laboratories has settled a US patent law suit with Astellas Pharma and Boehringer Ingelheim, allowing it to start selling generic capsules of Flomax one month before Astellas' patent protection ends.

According to a report by the USA’s Consumer Report in June, the price of the generic prostate drug doxazosin is $10 or less a month, whereas Flomax can be up to $246. This also noted that US consumers spent around $1.2 billion last year for the latter.