Monday, August 2, 2004

INTERMITTENT DOSING OF ROCHE, GSK'S BONIVA NEARLY AS EFFECTIVE AS ONCE DAILY

Compared with once-daily administration, an intermittent-dosing regimen of F. Hoffman-La Roche Ltd. and GlaxoSmithKline Plc's pharmaceutical brand Boniva (ibandronate sodium) was nearly as effective at reducing the incidence of new vertebral fractures after three years of treatment in women with postmenopausal osteoporosis, according to new data.

Researchers conducted a three-year, double-blind trial wherein 2,946 women aged 55 to 80 years were randomized to receive placebo, 2.5 mg of Boniva once daily or 20 mg of Boniva every other day for 12 doses at the start of each three-month interval. All participants also received 500 mg/day of calcium and 400 IU/day of vitamin D.

After three years, the rate of new vertebral fractures was significantly reduced in patients who received once daily (4.7 percent) or intermittent Boniva (4.9 percent), relative to placebo (9.6 percent), according to the authors of the study. Thus, once-daily and intermittent Boniva reduced the risk of new vertebral fractures by 62 percent and 50 percent, respectively, versus placebo.

In addition, bone mineral density within the lumbar spine increased 6.5 percent among patients receiving a daily dose of Boniva, 5.7 percent among those receiving it intermittently and 1.3 percent among those receiving placebo.

The study appeared in the August issue of the Journal of Bone Mineral Research.

Although a 2.5 mg once-daily formulation of Boniva was approved last year by the Food and Drug Administration, Roche and GSK have no plans to market this once-daily version, according to a press release. They also have no intentions of seeking FDA approval for the intermittent dosing regimen used in the study.

However, the companies did submit a supplemental New Drug Application for a once-monthly dosing formulation of Boniva to the FDA in May.