HZT-602

Horizon Therapeutics' second product candidate, HZT-602, is a combination oral drug product consisting of naproxen and famotidine, and is being developed for the reduction of the risk of naproxen-associated gastric and/or duodenal ulcers in patients who require use of naproxen. HZT-602 will potentially improve naproxen's GI safety profile without altering its ability to reduce pain and inflammation.

Naproxen: The World's Second Most Prescribed NSAID

Naproxen is a non-steroidal anti-inflammatory drug (NSAID) first marketed in 1976 in the United States as the prescription drug, Naprosyn. Naproxen remains a prescription-only drug in much of the world and is available in 250, 375 and 500 mg tablets as a BID (two times a day) product.

The FDA approved the use of naproxen sodium in the U.S. as an over-the-counter drug in 1991, where OTC preparations are sold under the trade name Aleve. Although naproxen is considered a highly effective NSAID, it is associated with disturbances in the gastrointestinal tract, which can lead to debilitating ulcerations in high-risk patient populations.

With 14 million prescriptions written for naproxen products in the U.S. in 2005, it is the second most widely prescribed NSAID. It is also widely used outside the U.S., and is the second most prescribed NSAID in Europe and Japan. By developing a naproxen and famotidine combination along with HZT-501, Horizon hopes to provide the market with GI friendly options of the two most prescribed NSAIDs worldwide for both chronic and acute patients.