New drugs for 2004
February 17, 2004 | 12:00am
Some of the most outstanding stories in medicine in 2004 will involve new drugs to treat an assortment of ills, new uses for existing medications, and the possible availability of some drugs now sold only by prescription to over-the-counter status.
Here are the drugs that are expected to produce a significant impact on health care in 2004.
• Cancer. A highly anticipated class of cancer drugs called anti-angiogenesis agents may finally become available. Anti-angiogenesis agents act by blocking the formation and growth of new blood vessels that feed tumors.
The drug, Avastin, is for the treatment of advanced colorectal cancer. Studies show that patients who received Avastin along with a particular chemotherapy regimen experienced a substantially longer survival time than patients who received chemotherapy only. The manufacturer of Avastin, Genentech, applied for approval of the drug in September.
• Sleep. For those who suffer seriously from loss of sleep, three new sleep drugs are nearing approval by the US Food and Drug Administration (FDA).
The maker of the drug Provigil, already prescribed for narcolepsy, is seeking FDA approval to expand its medical use to people with excessive sleepiness caused by either shift work or obstructive sleep apnea. Manufacturer Cephalon already received an "approved letter" from the FDA last October and is expected to work out precise labeling language for the new medical indications by early this year.
Provigil, which is also known by its generic name modafinil, was first approved in 1999. The two new uses for the drug have been supported by sleep specialists, but some doctors have warned that Provigil could be misused as a "lifestyle" drug that would make people substitute it for sleep.
Another drug before the FDA, Estorra, is a potential treatment for both chronic and transitory insomnia. It is nonaddictive and does not produce next-day side effects. Its manufacturer, Sepacor, is expecting a decision from the FDA this month. In a large study published recently in the journal Sleep, Estorra produced five to seven hours of uninterrupted sleep, a better result than similar drugs already on the market.
Finally, an insomnia medication called Indiplon is in its final stages of clinical research. The drug is being studied for several types of insomnia. Its manufacturer, Neurocrine Biosciences, says it expects to submit an application for approval this year.
• Incontinence. The first medication for the treatment of stress urinary incontinence, the most common type, is expected to win FDA approval early this year. Studies show that duloxetine significantly reduces the number of incidences of incontinence.
Stress urinary incontinence, which affects many elderly women, is caused by decreased muscle function at the bladder outlet. Urine can leak from an increase in abdominal pressure, such as that caused by sneezing or coughing.
Patients may soon gain convenient access to one class of important but still costly medications traditionally available only via prescription: Cholesterol-lowering statins.
In the US, Merck & Co., in a joint effort with Johnson and Johnson, says it will seek FDA approval to sell its cholesterol drug, Mevacor, over the counter, sometime this year. Three years ago, two companies, including Merck, sought approval to make their cholesterol drugs available without a prescription but were turned down. Statins are drugs that lower cholesterol. In use for about 15 years, the drugs – there are many brands on the market – are considered safe and effective for most people. The time may be right for a change because doctors believe many more people could benefit from taking statins. (They already are one of the most frequently prescribed drugs). Also, the FDA is interested now in converting more drugs to over-the-counter status as a way to help reduce overall health-care spending.
When the FDA turned down the companies’ requests in 2000, regulators said one reason for the denial was that the dosage being sought for the over-the-counter statins – 10 mg – would be too low. It is likely that the company will request a dosage of 20 mg if they reapply, said Merck spokesman Tony Plohores.
Bristol-Myers Squibb Co. is also considering asking the government to approve Pravachol, another statin, for over-the-counter use, a company spokesman said.
Men and women seeking to get rid of facial lines and wrinkles, or to plump up their lips, will have new, longer-lasting alternatives to collagen and botox this year. Two of them are made from hyaluronic acid gel, which is a natural component of the skin.
Two months ago, the FDA approved the facial filler Restylane, made from hyaluronic acid found in roosters’ combs. An advisory in late November recommended approval of a synthetic form of hyaluronic acid called Hylaform, which is likely to get the drug agency’s go-ahead as well.
The long-standing controversy over silicone gel breast implants may reach a milestone in 2004 if the FDA decides to allow the devices to be sold again. They’ve been banned since 1992, although breast cancer survivors and some healthy women have been able to get them through research studies. In mid-October, an FDA advisory panel voted nine to six to approve the devices made by a company called Inamed.
Although the FDA typically goes along with its advisory panel’s recommendations, little is certain when it comes to silicone implants.
The FDA announced in July that it would begin allowing food manufacturers to submit petitions to make health claims based on a wide range of scientific evidence. That step would be a boon for the introduction of more "functional foods" promoted for their ability to improve health or lower disease risks. Back in 1999, Benecol became the first margarine you could put on your bread specifically to reduce bad cholesterol. It contains plant sterols, which keep the body from absorbing the cholesterol in foods.
With the FDA opening the door to more food claims, several US companies, late in 2003, announced that they were introducing other products fortified with these plant sterols. Lifeline Food Co. launched its Lifetime Low Fat Cheese in cheddar, mozzarella, and jalapeno Jack. Minute Maid made it possible to drink sterols in your morning juice with its Premium Heart Wise orange juice, and Rice Dream added heartwise, dairy-free rice drink to its product line. All three labels inform consumers that plant sterols "when part of a diet low in saturated fat and cholesterol, may help reduce the risk of heart disease by lowering cholesterol levels."
Other food companies continue to fortify more products with other beneficial kinds of fats. Smart Balance added to its heart-healthy line a new margarine, Smart Balance Omega Plus, containing both plant sterols and omega-3 fatty acids from menhaden, a plentiful fish that has long provided oil for European margarines.
Fitness equipment is getting smarter, too, thanks to sophisticated computer technology that gives users more information about their workouts. That, in turn, will lead to shorter, more efficient routines. Some cardio machines already come equipped with portals to plug in PDAs to track fitness progress, and others have built-in wireless heart rate monitors.
This year, EVO Fitness will introduce a treadmill with a computerized system that senses if users are pronating (rolling the foot inward) or supinating (rolling the foot outward). The deck of the treadmill then stabilizes to balance the runner’s gait. Also look for small, portable machines that can be taken on vacation.
This 2004, there are no excuses for not staying in shape!
Here are the drugs that are expected to produce a significant impact on health care in 2004.
• Cancer. A highly anticipated class of cancer drugs called anti-angiogenesis agents may finally become available. Anti-angiogenesis agents act by blocking the formation and growth of new blood vessels that feed tumors.
The drug, Avastin, is for the treatment of advanced colorectal cancer. Studies show that patients who received Avastin along with a particular chemotherapy regimen experienced a substantially longer survival time than patients who received chemotherapy only. The manufacturer of Avastin, Genentech, applied for approval of the drug in September.
• Sleep. For those who suffer seriously from loss of sleep, three new sleep drugs are nearing approval by the US Food and Drug Administration (FDA).
The maker of the drug Provigil, already prescribed for narcolepsy, is seeking FDA approval to expand its medical use to people with excessive sleepiness caused by either shift work or obstructive sleep apnea. Manufacturer Cephalon already received an "approved letter" from the FDA last October and is expected to work out precise labeling language for the new medical indications by early this year.
Provigil, which is also known by its generic name modafinil, was first approved in 1999. The two new uses for the drug have been supported by sleep specialists, but some doctors have warned that Provigil could be misused as a "lifestyle" drug that would make people substitute it for sleep.
Another drug before the FDA, Estorra, is a potential treatment for both chronic and transitory insomnia. It is nonaddictive and does not produce next-day side effects. Its manufacturer, Sepacor, is expecting a decision from the FDA this month. In a large study published recently in the journal Sleep, Estorra produced five to seven hours of uninterrupted sleep, a better result than similar drugs already on the market.
Finally, an insomnia medication called Indiplon is in its final stages of clinical research. The drug is being studied for several types of insomnia. Its manufacturer, Neurocrine Biosciences, says it expects to submit an application for approval this year.
• Incontinence. The first medication for the treatment of stress urinary incontinence, the most common type, is expected to win FDA approval early this year. Studies show that duloxetine significantly reduces the number of incidences of incontinence.
Stress urinary incontinence, which affects many elderly women, is caused by decreased muscle function at the bladder outlet. Urine can leak from an increase in abdominal pressure, such as that caused by sneezing or coughing.
In the US, Merck & Co., in a joint effort with Johnson and Johnson, says it will seek FDA approval to sell its cholesterol drug, Mevacor, over the counter, sometime this year. Three years ago, two companies, including Merck, sought approval to make their cholesterol drugs available without a prescription but were turned down. Statins are drugs that lower cholesterol. In use for about 15 years, the drugs – there are many brands on the market – are considered safe and effective for most people. The time may be right for a change because doctors believe many more people could benefit from taking statins. (They already are one of the most frequently prescribed drugs). Also, the FDA is interested now in converting more drugs to over-the-counter status as a way to help reduce overall health-care spending.
When the FDA turned down the companies’ requests in 2000, regulators said one reason for the denial was that the dosage being sought for the over-the-counter statins – 10 mg – would be too low. It is likely that the company will request a dosage of 20 mg if they reapply, said Merck spokesman Tony Plohores.
Bristol-Myers Squibb Co. is also considering asking the government to approve Pravachol, another statin, for over-the-counter use, a company spokesman said.
Two months ago, the FDA approved the facial filler Restylane, made from hyaluronic acid found in roosters’ combs. An advisory in late November recommended approval of a synthetic form of hyaluronic acid called Hylaform, which is likely to get the drug agency’s go-ahead as well.
The long-standing controversy over silicone gel breast implants may reach a milestone in 2004 if the FDA decides to allow the devices to be sold again. They’ve been banned since 1992, although breast cancer survivors and some healthy women have been able to get them through research studies. In mid-October, an FDA advisory panel voted nine to six to approve the devices made by a company called Inamed.
Although the FDA typically goes along with its advisory panel’s recommendations, little is certain when it comes to silicone implants.
With the FDA opening the door to more food claims, several US companies, late in 2003, announced that they were introducing other products fortified with these plant sterols. Lifeline Food Co. launched its Lifetime Low Fat Cheese in cheddar, mozzarella, and jalapeno Jack. Minute Maid made it possible to drink sterols in your morning juice with its Premium Heart Wise orange juice, and Rice Dream added heartwise, dairy-free rice drink to its product line. All three labels inform consumers that plant sterols "when part of a diet low in saturated fat and cholesterol, may help reduce the risk of heart disease by lowering cholesterol levels."
Other food companies continue to fortify more products with other beneficial kinds of fats. Smart Balance added to its heart-healthy line a new margarine, Smart Balance Omega Plus, containing both plant sterols and omega-3 fatty acids from menhaden, a plentiful fish that has long provided oil for European margarines.
This year, EVO Fitness will introduce a treadmill with a computerized system that senses if users are pronating (rolling the foot inward) or supinating (rolling the foot outward). The deck of the treadmill then stabilizes to balance the runner’s gait. Also look for small, portable machines that can be taken on vacation.
This 2004, there are no excuses for not staying in shape!
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