Pfizer Reports Positive Results For Phase III Trials Of Investigational Back Pain Drug Alo-02
Pfizer has announced the top-line Phase III trial results of its investigational drug ALO-02. The lower back pain treatment hit its primary efficacy endpoints and demonstrated statistically significant differences from placebo in the trials.
The company developed ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) to treat patients with chronic low back pain ranging from moderate to severe pain levels. ALO-02 capsules contain pellets comprised of opioid agonist oxycodone hydrochloride on extended-release mechanisms. The opioid agonist surrounds sequestered opioid receptor agonist naltrexone hydrochloride. ALO-02 functions in such a specific way that when used properly, naltrexone remains isolated and patients receive oxycodone on an extended release guided period of time. However, when ALO-02 pellets are crushed for possible misuse or abuse intents, naltrexone is relinquished and begins to counteract the effects of oxycodone.
Pfizer assessed patients across 47 sites in 21 states including Pennsylvania and New Mexico. The drug was proven effective in patients 18 years and older who have previously required around the clock opioid analgesics to relieve chronic lower back pain for extended periods of time. ALO-02 was tested in a 12-week randomized study completed in June of last year. The study was double-blind and placebo-controlled.
Patients who took 10-80 mg of ALO-02 twice per day during the 4-6 week, open label titration period were randomized to the 12 week, double blind period during which they either maintained current ALO-02 dose regimen or were tapered to placebo. Patients self-reported pain levels daily on a numeric rating scale.
ALO-02 achieved its primary endpoint against placebo of significant mean changes in pain numerical ratings. Pfizer reported common adverse reactions to ALO-02 such as nausea, diarrhea, and vomiting during the double-blind period.
Victoria Davis, spokesperson of Pfizer, said the company plans to submit an NDA application for ALO-02 probably in the last quarter of 2014.
Aside from ALO-02, the company also developed and markets opioid-based painkillers Embeda (morphine sulfate and naltrexone hydrochloride) and Avinza (morphine sulfate extended-release) capsules.
Source:
http://www.pfizer.com/news/press-release/press-release-detail/pfizer_reports_top_line_results_from_alo_02_phase_3_study
http://www.fdanews.com/articles/161958-pfizer-trumpets-positive-phase-iii-results-of-back-pain-drug