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Bayer to launch OTC omeprazole in Germany

Published on 17/07/09 at 10:00am

Bayer Vital, the marketing arm of Bayer HealthCare, is to launch the proton pump inhibitor omeprazole as an over-the-counter heartburn treatment.

It will first be brought to the German market next month under its existing prescription-only brand name Antra, and Bayer is expected to make it available as an OTC treatment in other European countries soon.

Bayer, whose consumer gastrointestinal portfolio currently includes Rennie, Talcid and Lefax, has licensed OTC rights to the drug from AstraZeneca, though the latter will continue to market omeprazole as a prescription-only medicine.

Bayer's plans would bring Antra into direct competition with GlaxoSmithKline's Zanprol in the UK, where GSK's OTC version of the off-patent omeprazole was launched five years ago.

As a prescription drug omeprazole had been one of the biggest-selling ever, making AstraZeneca's name as the brand Losec.

GSK renamed it and added the drug to its Zantac range in the most significant POM-P switch seen at that time, giving patients access to a superior heartburn treatment.

The proton pump inhibitor (PPI) drug is more powerful than other OTC remedies such as Zantac and Reckitt Benckiser's Gaviscon.

But the move did signal a shift of responsibility towards pharmacists diagnosing and treating the disease independently of doctors.

PPIs are the standard treatment and the most frequently prescribed medicines for acid-related gastrointestinal diseases and disorders.

For Antra, the OTC maximum daily dose will be 20mg, with a maximum pack size of 14 tablets (280mg). One tablet will be effective for up to 24 hours, the manufacturer says.

Antra has been approved in Germany with prescription since 1989 and, in addition to selling it as a prescription brand, AstraZeneca will full rights to the drug's patent-protected MUPS tablet and its formulation.

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