Ibuprofen and famotidine combination 'reduces pain and GI ulcers'

A drug that combines ibuprofen and famotidine reduces the incidence of gastrointestinal (GI) ulcers while also reducing pain, its manufacturer has announced.

Horizon Therapeutics said that a Phase III clinical trial of HZT 501 (800 mg ibuprofen and 26.6 mg famotidine) revealed that patients taking the drug had fewer incidences of GI ulcers compared to those taking ibuprofen alone.

It has long been known that ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDs), which are widely prescribed for pain management in arthritis, cause GI ulcers and other problems in the GI tract. Famotidine is currently used to treat stomach ulceration caused by NSAIDs.

"NSAIDs, while highly effective in treating pain and inflammation, often lead to serious safety concerns, including significant gastrointestinal damage," said Timothy Walbert, president and chief executive officer of Horizon Therapeutics.

In the drug manufacturer's trial, 1,500 people with mild to moderate pain caused by a range of factors including osteoarthritis were randomly divided into two groups.

The first group was treated with HZT 501 or 800mg of ibuprofen three times a day for 24 weeks or until patients developed diagnosed GI ulcers. Endoscopies were carried out at baseline, eight weeks, 16 weeks and 24 weeks.

Results showed that patients treated with HZT 501 had a statistically significantly fewer incidences of gastric or duodenum ulcers compared to the ibuprofen group.

Dr Loren Laine of the University of Southern California, commented: "These results indicate that HZT 501 can reduce the risk of ulcers, potentially improving the GI safety for patients treated with NSAIDs."

A spokesman for the Arthritis Research Campaign said there was an urgent need for more effective pain-relieving drugs for arthritis patients without unacceptable side effects.

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