Once-a-Month Osteoporosis Drug Approved
Boniva Is First Monthly Pill for Any Chronic Disease
March 28, 2005 - A new
drug allows people to protect their bones by taking just one pill a month.
Today the FDA approved a once-a-month version of the osteoporosis drug Boniva. The approval makes the drug the first once-a-month medicine designed to treat postmenopausal osteoporosis or any other chronic disease.
Boniva is part of a class of osteoporosis drugs known as bisphosphonates, which help build and maintain bone density (a measure of bone strength) in people with osteoporosis. Other drugs in this class include Actonel and Fosamax, but these must be taken daily or weekly.
Once-monthly Boniva is expected to become available in U.S. pharmacies in April. Boniva is also available as a daily osteoporosis drug.
12 Pills a Year
Nearly 50 million Americans over 50 are affected by or at risk for osteoporosis, mostly postmenopausal women.
Currently, other bisphosphonates are prescribed as daily or once-a-week pills. Researchers say the new treatment option may allow some people with osteoporosis to cut back on the number of pills they take to 12 tablets per year.
The once-monthly pill should be taken with plain water in the morning, and users should remain upright and avoid other foods or drinks for at least 60 minutes. This is to prevent the pill from getting stuck in the esophagus and causing damage and trouble swallowing.
Works as Well as Daily
The FDA approved the once-a-month version of Boniva based on clinical trials involving 1,602 postmenopausal women with osteoporosis. The studies showed that the once-monthly osteoporosis drug was at least as good as the daily dose in increasing bone density of the spine and lower back after one year of treatment.
Boniva is not recommended for people who are unable to stand or sit upright for at least 60 minutes, people with high calcium levels, or people with sensitivities to bisphosphonates. The most common side effects of bisphosphonates include stomach disorders and ulcers.
Boniva is made by Roche and GlaxoSmithKline. GlaxoSmithKline is also a WebMD sponsor.