MHRA reclassifies Pfizer’s Nexium Control as an OTC treatment for heartburn

Jan 31 2015

Pfizer is pleased to announce that the MHRA has approved the reclassification of the well-established proton pump inhibitor (PPI) Nexium Control^® (esomeprazole), making it available for consumers to purchase it without a prescription.

PPIs, recommended by NICE as a first-line treatment for heartburn, have a long safety history when used in accordance with the label instructions. With heartburn regularly affecting more than 8 million people across the UK, the reclassification of Nexium increases treatment options available OTC and presents greater accessibility, therefore enabling heartburn sufferers to self-manage their symptoms more effectively. It is also hoped this reclassification will also help relieve some of the burden on GPs through appropriate and effective self-care, in line with government strategy.

The launch of Nexium Control^® as an OTC medicine will be welcome news for the 1 in 6 UK adults who experience frequent heartburn, twice or more a week. Frequent heartburn is not only common, but it can have a negative impact on a person’s quality of life throughout the day and night – from limiting a person’s food and drink choices through to sleep disruption.

Nexium Control^® provides 24-hour protection from heartburn and is indicated in the UK for short-term management of reflux symptoms (heartburn, acid regurgitation) in adults aged 18 or over. The OTC treatment is recommended for a maximum of 14 consecutive days, and heartburn sufferers are advised to contact a healthcare professional should symptoms persist.

Dr Toby Shephard, Medical Director, Pfizer Consumer Healthcare, says:

Pfizer welcomes the news that the MHRA has reclassified Nexium Control^® as an OTC treatment for heartburn. This common condition, affecting over 8 million people in the UK, often impacts a person’s day-to-day life, but it can generally be effectively self-managed with the right treatment. We hope by allowing frequent heartburn sufferers greater access to this clinically-effective PPI treatment, it will help more people take better control of their symptoms without the need to see a GP unless symptoms persist.

Nexium Control^® offers an important, alternative option to antacids or alginates which, until now, have been the main options available for people to self-select from pharmacies and supermarkets. Antacids and alginates provide immediate relief, but do not deliver the sustained relief that some frequent sufferers need and want to keep their symptoms under control. By blocking acid production in the stomach, Nexium Control^® can provide 24-hour protection against heartburn with just one tablet a day.

Kirit Patel, Chief Executive, Day Lewis Pharmacy, comments:

Frequent heartburn is a common reason for repeat visits to the pharmacy. Our role as pharmacists is mainly to advise customers on the best treatment to suit their individual needs, and to provide advice on contraindications and when to seek further medical advice if symptoms persist. The reclassification of Nexium as an OTC treatment is good news as it provides customers with access to another effective heartburn medication.

Dr Toby Shephard, Medical Director, Pfizer Consumer Healthcare, says:

Allowing frequent heartburn sufferers to have greater access to treatments with a long safety history, supports current UK government objectives around increasing appropriate self-management of conditions. Nexium Control^® is an example of a well-established, first line treatment that has been available on prescription for many years and demonstrates Pfizer’s commitment to improving consumer access to affordable healthcare options, empowering people to take charge of their health, and reducing the burden on the NHS.

Pfizer acquired the rights to market non-prescription Nexium from AstraZeneca and will be available from pharmacies and supermarkets across the country from mid-February 2015. Nexium Control^® was approved for non-prescription sale by the European Medicines Agency (EMA) in 2013 for all 28 countries in the European Union and is already available in Germany, France, Italy, Malta and Ireland. In the UK, Nexium Control^® has been reclassified as General Sales List (GSL) and is available in 7 (RRP £6.99) or 14 tablet packs (RRP £11.99).

Within the GSL classification, Nexium Control^® has a maximum treatment period of 14 days, after which patients are instructed to consult a doctor if no symptom relief is obtained. In addition there are clear instructions in the patient leaflet and on the packaging to aid patients in identifying signs and symptoms for which they should seek advice from a healthcare professional.

The launch of Nexium Control^® is being supported by on-going pharmacy training and trade support in addition to an extensive consumer launch campaign from mid-February to educate about the product including TV advertising, PR, online and Point of Sale display. The consumer website is launching on 3rd February and can be found at www.nexiumcontrol.co.uk.

Source: http://www.pfizer.co.uk/