Eisai has applied for a P licence for its proton pump inhibitor rabeprazole.

The company is seeking to make the prescription-only drug available for the short-term treatment of reflux-like symptoms in adults, in packets of 14 (10mg).

Eisai argues that rabeprazole is clinically proven to treat heartburn and has also pointed out that proton pump inhibitors omeprazole and pantoprazole had been approved as P medicines already.  

The patient information leaflet would include a list of symptoms that could indicate an underlying malignant condition, Eisai added. And patients should be advised to see their doctor if their symptoms persist after taking the medication for 14 days.

The Eisai also pledged to give pharmacists information on potentially problematic areas, such as high-risk groups and distinguishing heartburn symptoms from other conditions.

"The ‘alarm symptoms' that might indicate severe underlying disease… in patients presenting with heartburn are well-known to pharmacists and clearly communicated in the patient information supplied with all drugs for self-medication of dyspepsia," Eisai said. "The ‘direct danger' posed by rabeprazole use in pharmacy is very low."

The application is open for consultation until September 2.