FDAnews Drug Daily Bulletin

Zogenix Touts Positive Phase III Data for Zohydro ER

Feb. 14, 2014
Zogenix is trumpeting new Phase III data showing that its Zohydro ER hydrocodone bitartrate extended-release capsules are both well-tolerated and effective at treating moderate-to-severe chronic low back pain.

Study 801, which evaluated the drug’s efficacy and study 802, a long-term open-label safety study, comprised 1,100 patients and met their primary endpoints of significant pain relief as compared to placebo, as well as the secondary endpoint: 67.5 percent of patients experienced 30 percent improvement in pain intensity through the end of the study as compared to 31.1 percent of patients on placebo.

The FDA approved Zohydro ER in October 2013 for pain severe enough to require around-the-clock opioid treatment and for which alternative treatments had been ineffective. The agency’s decision ran counter to the concerns of its Anesthetic and Analgesic Drug Products Advisory Committee that Zohydro ER will “almost certainly cause dependence.”

A Feb. 12 letter from Republican Sens. Lamar Alexander (R.-Tenn.), Tom Coburn (R.-Okla.) and Mitch McConnell (R.-Ky.) reaffirmed those concerns and asked FDA Commissioner Margaret Hamburg how the agency plans to ensure that Zohydro ER and other opioids will be abuse-deterrent.

Zogenix has said that it is working on an abuse-deterrent form of the drug, but that it likely would not be available for another three years. — Lena Freund

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