Source: DGNews  |  Posted 2 years ago

By Jennifer Reising

SAN ANTONIO, Tex -- February 8, 2010 -- Tanezumab effectively and safely reduces pain associated with osteoarthritis (OA), interstitial cystitis, and chronic low back pain, according to a review of studies presented here at the 26th annual meeting of the American Academy of Pain Medicine (AAPM).

“We see that tanezumab improves pain across a variety of chronic pain states, especially chronic low back pain and interstitial cystitis, which are 2 very difficult chronic pain conditions to treat,” said Leslie Tive, PhD, Pfizer, Inc., New York, New York, on February 3.

Tanezumab is a humanised, anti-nerve growth factor antibody. Dr. Tive and colleagues reviewed results from 3 randomised, double-blind, placebo-controlled, 16-week trials, each conducted in 1 of 3 pain conditions: OA of the knee, chronic low back pain, and interstitial cystitis. The studies examined changes from baseline in pain following single or multiple tanezumab doses in a total of 725 patients.

The OA study was a multiple-dose study; patients were randomised to receive 1 intravenous (IV) infusion of tanezumab (10, 25, 50,100 or 200 mcg/kg) or placebo twice during the study, separated by an 8-week interval.

In the chronic low back pain study, patients were randomised to receive a single IV infusion of tanezumab (200 mcg/kg), naproxen 500 mg BID, or placebo.

Patients with interstitial cystitis were randomised to receive tanezumab (200 mcg/kg) or placebo.

Each clinical trial showed clinically significant pain reduction, as defined by >=30% reduction from baseline in index pain in the OA and low back pain studies and a change from baseline in the average daily pain score of >=1 point over placebo in the interstitial cystitis study.

Improvements in pain were greater with tanezumab than with placebo in the OA and low back pain studies (P < .05), and greater with tanezumab compared with naproxen in the low back pain study as well (P = .004).

Adverse events (AEs) were generally as expected for respective study populations with few rated as serious (0%-5.9%). AEs of abnormal peripheral sensation were reported by 13.5% of tanezumab-treated patients in the OA study, 12.5% in the chronic low back pain study, and 29.4% in the interstitial cystitis study. AEs were generally transient and not associated with substantial or clinically meaningful neurological deficits.

Funding for this study was provided by Pfizer, Inc.

Presentation title: Tanezumab, a Humanized Anti-Nerve Growth Factor Antibody in the Treatment of Three Chronic Pain Types. Abstract 151