Pharmacology
FDA Approves Once-a-Month Ibandronate Sodium Tablets for Postmenopausal Osteoporosis
By Akanksha, Pharmacology Correspondent
Mar 26, 2005, 09:48

The U.S. Food and Drug Administration (FDA) today approved once- monthly oral Boniva� (ibandronate sodium) 150 mg Tablets, the first and only once-a-month medicine for the treatment of postmenopausal osteoporosis.

Ibandronate sodium is the first-ever oral treatment administered as one tablet once a month for any chronic disease. With once-monthly ibandronate sodium, an effective bisphosphonate, patients would take 12 tablets a year versus 52 required with current weekly bisphosphonate treatments.

"Ibandronate sodium is the first and only once-monthly osteoporosis medication that maintains and actually builds bone density," said Ronald Emkey, M.D., clinical trial investigator and Medical Director of Radiant Research, Reading, PA. "The approval of this medication is significant because it offers patients a new treatment option that is effective and easy to take."

This new treatment option comes in the wake of the Surgeon General's Report elevating osteoporosis to a major public health threat on par with smoking and obesity.Forty-four million Americans over 50 years of age, are affected by or at risk for osteoporosis, which causes bones to become weak and more likely to break, and can result in severe pain, deformity, disability, hospitalization and even death.

To improve persistence, the Surgeon General's Report has recommended, among various measures, simplifying and organizing treatment regimens.

"Osteoporosis is a serious, widespread and growing public health threat. We welcome any new treatment options such as ibandronate sodium that will help patients address this all too prevalent disease," said Judith Cranford, Executive Director, National Osteoporosis Foundation.

Developed in response to patient need, once-monthly ibandronate sodium was approved based on a supplemental new drug application. Once-monthly oral ibandronate sodium is not currently approved for use outside of the U.S., although it is undergoing regulatory review in markets across the world, including Europe, where it will be marketed under the trademark Bonviva.

Ibandronate sodium 150 mg once-monthly and ibandronate sodium 2.5 mg daily are indicated for the treatment and prevention of postmenopausal osteoporosis. Once-monthly ibandronate sodium is expected to be available by prescription in U.S. pharmacies in April.

Daily ibandronate sodium (2.5 mg) was approved for the treatment and prevention of osteoporosis based on studies showing that, over three years, it significantly reduced the risk of new vertebral fractures in women with postmenopausal osteoporosis and increased bone mineral density (BMD) in postmenopausal women without osteoporosis. Once-monthly oral ibandronate sodium (150 mg) was approved based on results from the MOBILE study (Monthly Oral iBandronate In LadiEs), a randomized, double-blind, multinational, non-inferiority trial in 1,602 women with postmenopausal osteoporosis. MOBILE showed the following:


* The monthly dose was at least equivalent to the daily dose in
increasing BMD after one year at the lumbar spine and other skeletal
sites

* The mean increase from baseline in lumbar spine BMD was 4.9 percent in
the once-monthly group and 3.9 percent in the daily group (p=0.002)

* The once-monthly group also had consistently higher BMD increases at
the other skeletal sites compared to the daily group

Ibandronate sodium is contraindicated in patients unable to stand or sit upright for at least 60 minutes, with uncorrected hypocalcemia, or with known hypersensitivity to any component of ibandronate sodium. Ibandronate sodium, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcer. Ibandronate sodium is not recommended in patients with severe renal impairment. Adequate intake of calcium and Vitamin D is important in all patients.

Rarely, patients have reported severe bone, joint and/or muscle pain after taking bisphosphonate therapy for osteoporosis. Additionally, osteonecrosis of the jaw has rarely been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures.

The most commonly reported adverse events with once-monthly ibandronate sodium regardless of causality were abdominal pain (ibandronate sodium 150 mg 7.8 percent vs. ibandronate sodium 2.5 mg 5.3 percent), hypertension (6.3 percent vs. 7.3 percent), dyspepsia (5.6 percent vs. 7.1 percent), arthralgia (5.6 percent vs. 3.5 percent), nausea (5.1 percent vs. 4.8 percent) and diarrhea (5.1 percent vs. 4.1 percent).

Once-monthly ibandronate sodium is a small, film-coated, easy-to-swallow tablet dosed at 150 mg. Patients should take ibandronate sodium with plain water on an empty stomach upon rising in the morning. They should remain upright and avoid food, drink and other medications for at least 60 minutes.

"The patients in my clinical trials found easy ways to remember their once-monthly ibandronate sodium, such as writing a note on their calendar or taking it the first Sunday of each month," Dr. Emkey said. "This support program will be another useful tool for patients."

Osteoporosis (porous bones) is a disease in which bones become brittle and more likely to break. In the U.S. today, ten million individuals, eight million of whom are women, are estimated to already have osteoporosis, and almost 34 million more are estimated to have low bone mass (osteopenia),placing them at increased risk for osteoporosis. Unfortunately, the prevalence of osteoporosis is growing, especially as the number of postmenopausal women in the population continues to rise.

Together, osteoporosis and osteopenia are expected to affect an estimated 52 million women and men age 50 and older by 2010, and 61 million by 2020.2 Direct medical costs of osteoporosis total nearly $18 billion in the U.S. each year.

All rights reserved by www.rxpgnews.com