Pfizer cool on Prilosec OTC launch
pharmafile | October 29, 2003 | News story | |Â Â Â
Pfizer has criticised the US approval of an over-the-counter formulation of AstraZeneca's heartburn drug Prilosec, saying it will only serve to confuse the public.
The pharma company, which markets rival OTC treatment Zantac 75, pointed to concern within the medical profession that the FDA approval of Prilosec OTC could cause consumers to misunderstand their treatment options.
"Patients want and expect fast relief. They won get it with a drug like Prilosec," said Dr Brett Bernstein, Director of Ambulatory Services, Division of Digestive Diseases at New York Beth Israel Medical Centre. "Prilosec cannot be used on an as-needed basis for fast and effective relief."
The switch to make Prilosec (omeprazole, known as Losec in the UK) available over the counter is part of AstraZeneca's strategy to maximise sales of the ageing product, which lost patent protection several months ago and is facing competition from several generic versions.
The launch of the OTC version was delayed last year after the FDA requested a label change to make it more patient-friendly.
In the UK, the MHRA has given its approval for the drug to be switched to OTC status, and is now seeking views from stakeholders.
Prilosec OTC to be marketed by Procter & Gamblewill be the only non-prescription treatment available for frequent heartburn, which occurs two or more days a week and is estimated to affect over 50 million people in the US.
But Dr Bernstein said that 7 out of 10 heartburn patients only experience occasional episodes and H2 blockers such as Zantac 75 can stop their symptoms within 30 to 40 minutes, unlike Prilosec, which can take between one and four days to work fully.
P&G is drawing on a combination of Prilosec legacy as the biggest-selling prescription drug in the world between 1996 and 2000, its safety record and its first-in-class status as a treatment for frequent heartburn.
The drug will also benefit from three extra years of OTC marketing exclusivity granted after AstraZeneca conducted two additional clinical trials assessing the treatment efficacy in preventing heartburn over both a 24-hour period and the 14-day period in which patients must take it.
