Flip the calendar and take your pill.
Such will be the routine for osteoporosis patients who take Boniva, a once-a-month pill approved Friday by the U.S. Food and Drug Administration.
Boniva will be sold by two giant drug makers, Hoffmann-La Roche Inc. of Nutley and GlaxoSmithKline PLC, which say their product will be the first-ever tablet taken monthly for a chronic condition.
Other drugs in Boniva’s class are widely used for preventing and treating osteoporosis – and taken weekly. But they have a somewhat cumbersome regimen. Patients take them first thing in the morning on empty stomachs, must be sitting up when they ingest the pills and cannot lie down or eat for 30 minutes. The drugs can cause side effects such as stomach discomfort or heartburn.
Boniva patients will need to maintain similar regimens. But doctors hope reducing the pill frequency could help patients stay on their medications.
“Once-monthly medicine truly adds a new convenience to their lives that hopefully will let them stay on therapy longer,” said Fern Heinig, Roche’s brand director for Boniva.
Boniva is scheduled to reach pharmacies in the middle of next month. The drug was approved for women – who are afflicted by osteoporosis an estimated four times more often than men – for the treatment of postmenopausal osteoporosis.
“I’m very enthusiastic that we have another treatment option,” said Dr. Bess Dawson-Hughes, president of the National Osteoporosis Foundation. “No single or small group of drugs will be suitable for all patients.”
Osteoporosis is a bone-weakening disease that can progress painlessly and without symptoms until a bone breaks, usually in the hip, spine or wrist. One in two women and one in four men older than 50 will have an osteoporosis-related fracture, according to the National Osteoporosis Foundation.
Theoretically, Dawson-Hughes said, the need to take only 12 Boniva pills a year, compared with 52 for the weeklies, might help patients stay on the new drug or reduce the times they endure side effects. For chronic conditions such as osteoporosis and high cholesterol, some patients tend to lose interest in taking their medicines – in part because the drugs don’t provide the immediate relief the way a medication such as aspirin does for a headache.
Rather, Boniva and competing drugs are designed to be taken for years to cut the risk of bone fractures.
Dawson-Hughes said studies will test whether Boniva patients are more likely to maintain their therapy. She and others worry that because the drug is taken so infrequently, patients might forget it altogether.
“It’s impossible to guess how all of these things will balance out with this new drug, but it’s great to have a new drug to evaluate further along these lines,” said Dawson-Hughes, a professor of medicine at Tufts University.
Heinig said Boniva patients will be able to join a patient- support program and be alerted by postcard, phone call or e-mail to take their pills.
Roche won approval in 2003 for Boniva as a once-a-day option. But the company decided it would not make enough of a dent in a market of once-weekly versions of drugs in the same class – Fosamax from Merck, and Actonel from Sanofi-Aventis and Procter & Gamble.
The companies behind Boniva said the monthly drug showed in a test of 1,600 women that it was at least equivalent to the daily version in increasing bone mineral density after a year. Dr. Ralph Marcus, director of the Osteoporosis Center of North Jersey in Teaneck, said he would like to see more data on Boniva’s ability to reduce hip fractures, because strong data exist on that front for Fosamax and Actonel.
But that said, “some patients will certainly find it more convenient to take medicine once a month,” Marcus said. “And it may be more tolerable, because if side effects occur it may be only once a month instead of once a week.”
Patients must take Boniva when they wake up. They must remain upright and avoid food, drink and other medications for at least 60 minutes.
Boniva’s price will be comparable to other drugs in its class on a monthly basis, Heinig said.
Boniva is expected to be one of the newer drugs leading an explosion in the osteoporosis market. Annual revenues in the United States from such drugs are expected to climb from $3.3 billion in 2003 to $8.6 billion in 2010, according a January report by Frost & Sullivan, a consulting company.
Aside from bisphosphonates such as Fosamax and Actonel, drugs in other classes – such as Eli Lilly’s Evista – are either in development or on the market.
In the future, osteoporosis drugs may be taken even less regularly. Beyond the monthly, Roche expects to hear from the FDA later this year about its intravenous version of Boniva taken every three months. Companies such as Novartis and Amgen are testing osteoporosis drugs that would be administered even less frequently.
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