FDA Approves Pfizer's Over-the-Counter Nexium For Heartburn

Pfizer announced in press release that the Food and Drug Administration (FDA) has approved over-the-counter Nexium 24HR (esomeprazole 20mg). Previously available by prescription only, the heartburn drug is now available over-the-counter (OTC), providing easier access to patients. Paul Sturman, President of Pfizer Consumer Healthcare said, “Switching medicines, whenever appropriate, from prescription to non-prescription status improves access, empowers consumers to care for their own health and is an important strategy for Pfizer. The FDA approval of Nexium 24HR is a significant milestone in executing against our plan.”

Heartburn

Heartburn is a painful or burning feeling that wells in the chest, spreading to the throat or neck. Most people have had heartburn at least once or a few times. People that experience it frequently are diagnosed with gastroesophageal reflux disease (GERD). The condition occurs when a muscle closes off the end of the esophagus during the ingestion of food or liquid. If the muscle does not close completely, acid from the stomach backs up into the esophagus, irritating it and causing the sensation of heartburn. Some medicines can also cause heartburn.

Nexium

The FDA approved AstraZeneca’s Nexium in 2001 for erosive esophagitis. Pfizer acquired the rights in 2012 for non-prescription Nexium. Nexium (esomeprazole) helps alleviate GERD symptoms, aids in healing the damaged esophagus, and guards against further damage.  When people are taking non-steroidal anti-inflammatory drugs (NSAIDs), Nexium helps prevent against the development of ulcers in the intestine or stomach. The medication is also used with bacteria-induced stomach ulcers and Zollinger-Ellison syndrome.

Under the terms of the 2012 agreement between AstraZeneca and Pfizer, Pfizer will hold global rights to market NEXIUM. Pfizer made an upfront payment of $250 million and will continue to make royalty and milestone payments based on regulatory approvals, product launches, and sales. With the FDA approval, Pfizer plans to distribute Nexium over the counter as soon as possible, and is seeking similar approvals in Europe.

The companies had previously agreed to discuss other OTC versions of AstraZeneca drugs. They signed a “right of first refusal,” wherein Pfizer gets the first shot at OTC rights for Rhinocort Aqua, a glucocorticosteroid for non-infectious rhinitis. With the FDA approval, the companies are much more likely to see the OTC partnership as fruitful.