Top-Line Results With Novel Chronic Pain Drug Positive

Megan Brooks

Authors and Disclosures

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August 26, 2011 — Zogenix, Inc, has announced positive top-line results from a pivotal phase 3 efficacy study of its extended-release capsule formulation of hydrocodone bitartrate (Zohydro).

The product is novel, in that it does not contain acetaminophen.

"If approved, Zohydro could be the first extended-release hydrocodone treatment available without acetaminophen, which is associated with an increased risk of liver toxicity when used in high doses over time," the company notes in a statement.

Study 801 Meets Primary End Point

The drug is being evaluated for the treatment of moderate to severe chronic pain in patients requiring 24-hour opioid therapy for an extended period.

In Study 801, the drug met the primary end point by providing significantly better pain relief (P = .008) compared with placebo, the company reported.

Study 801 was a multicenter, randomized, double-blind, placebo-controlled study involving more than 300 opioid-experienced adults with inadequately controlled moderate to severe chronic lower back pain.

The trial consisted of an open-label conversion and titration phase of the new agent followed by a 12-week placebo-controlled treatment phase comparing Zohydro 20 to 100 mg every 12 hours to placebo.

The primary efficacy endpoint was the mean change from baseline to the end of 12 weeks of treatment in the average 24-hour pain intensity ratings based on the 0 to 10 Numerical Rating Scale from daily electronic diaries comparing the drug and placebo.

Results "Encouraging"

In addition to providing significantly better pain relief than placebo, the study also met 2 key secondary endpoints: the proportion of patients with at least 30% improvement in pain intensity and an improvement of overall satisfaction with the medication.

The drug was safe and well tolerated. The most commonly reported adverse events in patients treated with this formulation (>5%) were constipation, nausea, and urinary tract infection.

"We are very encouraged by the study results, which we believe are meaningful for patients suffering from moderate to severe chronic pain," Stephen J. Farr, PhD, Zogenix president and chief operating officer, said in a prepared statement.

"Zohydro will offer hydrocodone for the first time in a convenient 12-hour dose while eliminating acetaminophen," Dr. Farr noted. The new formulation "may simplify physicians' ability to prescribe the appropriate hydrocodone dose for chronic pain while managing the inadvertent overuse of acetaminophen, which is a common ingredient in combination pain products and over-the-counter medications," he added.

Zogenix plans to submit a new drug application for this product to the US Food and Drug Administration by early 2012.