FDA Approves AstraZeneca, Nektar Constipation Drug--Update

By Razak Musah Baba 
 

The U.S. Food and Drug Administration approved a once-daily constipation drug from AstraZeneca PLC (AZN, AZN.LN) and Nektar Therapeutics (NKTR) for adult patients with chronic, non-cancer pain.

The drug--called Movantik--is expected to be available to patients in the first half of next year.

"The FDA approval of Movantik provides a new treatment option for adult patients with chronic non-cancer pain suffering from opioid-induced constipation, a common side effect of opioid therapy," said Dr. Briggs Morrison, executive vice president, global medicines development & chief medical officer, AstraZeneca.

Movantik was developed using Nektar Therapeutics (NKTR) technology as part of an exclusive global licensing agreement with the U.K.-based pharmaceutical company. The companies also have filed for regulatory approvals in Europe and Canada.

San Francisco-based Nektar said AstraZeneca agreed to conduct a cardiovascular safety study, which the FDA is requiring after Movantik's launch. In June, an FDA advisory panel recommended post-marketing studies for Movantik and other drugs in its class.

Nektar shares rose 2.8% to $13.91 in recent trading, while AstraZeneca's American Depositary Receipts slipped 18 cents to $73.59.

--Tess Stynes contributed to this article.

-Write to Razak Musah Baba at [e-mail]

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