FDA approves new Actonel dose

Apr 18 2007

The U.S. Food and Drug Administration (FDA) approved a new dose for Actonel (risedronate sodium tablets) that will give patients the option of taking one Actonel 75 mg tablet on two consecutive days, for a total of two tablets monthly, to treat and prevent their postmenopausal osteoporosis.

Actonel, a therapy proven to reduce the risk of both vertebral and nonvertebral fractures in postmenopausal women with osteoporosis, will soon be available in this monthly two-day dose option. In previous clinical trials of daily Actonel 5 mg, nonvertebral fracture reduction was demonstrated at a composite endpoint of six sites commonly associated with osteoporotic fractures - leg, humerus, hip, wrist, collarbone, and pelvis.

The approval of Actonel 75 mg is based on an active-controlled, double- blind clinical trial of 1,229 postmenopausal women with osteoporosis aged 50 years or older with a lumbar spine bone mineral density (LS BMD) T-score less than or equal to -2.5 OR a LS BMD T-score less than or equal -2.0 and at least one prevalent vertebral fracture. In the trial, increases in bone mineral density (BMD) at the lumbar spine, total hip, and hip trochanter in patients treated with Actonel 75 mg, taken on two consecutive days a month, were similar to those in patients treated with Actonel 5 mg daily at both time points measured (6 and 12 months). Both treatments were generally well tolerated with adverse events between the two groups being similar.

"In previous trials, daily Actonel therapy has been proven to protect patients from both vertebral and nonvertebral fractures," said Michael McClung, M.D., Founding Director of the Oregon Osteoporosis Center in Portland, Oregon. "This new monthly two-day dose may be appealing to patients looking for the convenience of less frequent dosing with Actonel."

The full prescribing information for different bisphosphonate therapies recommends different wait times between taking therapy in the morning and the first consumption of food or drink other than plain water. One Actonel 75 mg tablet taken on two consecutive days, for a total of two tablets monthly, offers patients a monthly dosing regimen with a recommended waiting period of at least 30 minutes. With Actonel, patients can get their morning coffee up to 30 minutes sooner than with ibandronate 150 mg tablets, taken once monthly, which requires a wait of at least 60 minutes. There are no head-to-head studies comparing the safety and efficacy of risedronate and ibandronate.