FDAnews Drug Daily Bulletin

Pfizer Trumpets Positive Phase III Results of Back Pain Drug

Jan. 24, 2014

A Phase III study has shown that Pfizer’s investigational ALO-02 was effective at relieving moderate-to-severe chronic lower back pain in patients 18 years and older who have required around-the-clock opioid analgesics for an extended time, the drugmaker said Thursday.

The 12-week, double-blind, placebo-controlled, randomized study completed in June 2013 evaluated patients at 47 sites across 21 states, including Pennsylvania, Maryland and New Mexico. Results showed that the study met its primary endpoint of significant mean changes in pain numerical rating scales between ALO-02 and placebo.

Pfizer spokesperson Victoria Davis told Drug Daily Bulletin the drugmaker plans to submit an NDA for ALO-02 sometime during the fourth quarter of this year.

ALO-02 contains extended-release oxycodone hydrochloride. Pfizer also makes the opioid painkillers Embeda (morphine sulfate and naltrexone hydrochloride), Oxecta (oxycodone HCl) and Avinza (morphine sulfate extended-release capsules). — Lena Freund

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