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FDA Places New Heart-Safety Hurdle in Path of Opioid Constipation Drugs

KODIAC refers to a series of phase III studies designed to determine the efficacy and safety of naloxegol in patients taking opioids for non-cancer pain. One of the KODIAC studies compares the safety of naloxegol versus "usual care" over one year but results won't be known until early next year. The two shorter efficacy studies of naloxogel reported positive results Monday.

"We do not comment on ongoing discussions with the FDA," said AstraZeneca spokesman Tony Jewell, in response to questions about how naloxegol might be affected by FDA's new safety concerns with OIC drugs.

Nektar executives declined to answer questions but the company is holding a conference call on Monday to review third-quarter results and the naloxogel study results.

FDA has not spoken publicly about why it's now concerned about the long-term safety of OIC drugs but it may have to do with a higher rate of heart attacks associated with Entereg, a drug sold by Cubist approved to speed the recovery of bowel function in patients following abdominal surgery.

Entereg is also a mu-opioid antagonist like the current class of OIC drugs in development. Entereg's FDA-approved label includes a warning about increased risk of heart attacks, although it's not clear if Entereg is the cause.

Last month, Cubist started a phase III program for its OIC drug candidate CB-5945. Enrollment of 1,400 patients in a one-year safety study has begun, with efficacy studies starting next year.

"We have had extensive discussions with the FDA on our phase III program including the design of the large and well controlled (placebo vs CB-5945) safety trial. We continue to believe that this large well controlled safety trial would be acceptable for approval," said Cubist spokesman Francis McLoughlin.

-- Reported by Adam Feuerstein in Boston.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
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