New drugs for the new year

These are exciting times in the field of medicine. For one, 2003 will see the biggest crop of new drugs in years. The US Food and Drug Administration (FDA) is expected to approve 40 percent more new pharmaceuticals in 2003 compared to last year. These medications hold promise for millions of people who suffer from depression, cancer, impotence, psoriasis and other afflictions. While it can be tricky predicting which drugs are likely to receive FDA approval, several breakthrough medicines have completed pre-market testing and are only awaiting final clearance.

Two of the first drugs expected to make their debut are FluMist, the first inhaled influenza vaccine, and Amevive, a psoriasis medication that relieves symptoms in an entirely new way. Amevive works by halting the underlying immune system reaction that triggers the itching, scaling and redness that typifies the condition. Later in the year, Raptiva, a similarly acting psoriasis drug, will probably be approved as well.

In addition, best-selling prescription remedies, including antibiotic Cipro, the sleeping aid Sonata, and the wrinkle cream Renova, will lose their patent protection, which means that cheaper generic versions should be available. And Prilosec, the popular ulcer medication that recently went off patent, is expected to be available in an over-the-counter version in the US.

Here’s a look at some other promising medications that, at this time, look like good bets for approval in 2003.

• Impotence. Two new drugs, Cialis and Levitra, may finally make their debut this year, challenging Viagra in the impotence treatment category. Cialis, which is already approved in Europe, has been shown to last three times longer than Viagra, up to 36 hours. And Levitra is said to work about twice as fast as Viagra, in 20 minutes compared with about 40 minutes for the rival drug. Also, both new drugs have been found to have fewer side effects than Viagra.

• Depression. For the millions of people around the world who suffer from depression, drugs such as Prozac have been lifesavers. But these medications typically take two to four weeks to become effective, and some patients get frustrated and quit before that. Also, up to two-thirds of depression sufferers derive little or no benefits from these treatments.

But a new antidepressant, Cymbalta, which is expected to be available in the first half of 2003, may help these patients. This novel antidepressant enhances levels of two brain chemicals that regulate mood, norepinephrine and serotonin. In contrast, popular antidepressants, like Prozac and Paxil, only boost levels of serotonin. Cymbalta also works faster. Tests show depressed patients experience a significant improvement in their mood within a week.

• ADHD. Medication can help children with attention deficit hyperactivity disorder, which by some estimates may affect up to five percent of school-age kids. But parents often have a tough time getting their child to take pills twice a day, especially given the stigma attached to the drugs normally used to treat this disorder.

The MethyPatch, a daily skin patch that dispenses methylphenidate (the active ingredient in established ADHD treatments such as Ritalin), may give parents another option. The discreet patch can be worn on the hip for 12 hours. The patch will also enable children to control their dosage: The patch can be removed earlier in the day if they get too edgy, or in the evening if they have trouble sleeping.

• Cancer. Lung cancer is one of the toughest cancers to treat because it’s normally not diagnosed until the cancer is advanced. But for the thousands of patients expected to be diagnosed with lung cancer this year, a new drug, Iressa, may offer some hope.

This novel cancer drug interferes with the molecular switches responsible for tumor growth. In studies of patients with metastatic lung cancer, whose tumors had spread to the other lung or another organ, the medication shrank tumors by at least half in about 10 percent of test subjects.

While the results seem modest, Iressa is considered a significant advance since few patients with metastatic disease respond to treatment. The drug is also the first in an anticipated wave of similarly acting drugs, like Erbitux, that precisely target cancer cells at the molecular level rather than killing healthy tissues, too, like today’s toxic chemotherapies.

Heart Disease

A new medical device – a tiny drug-coated stent about the size of the spring in a ballpoint pen – is about to revolutionize the treatment of coronary heart disease.

By delivering medication directly into the arteries, this new stent promises to make angioplasty a more effective and longer-lasting treatment for people with severe chest pain or heart attacks.

Although angioplasties have spared millions of patients the risks and pain of open-heart surgery, the procedures often fail. Up to 40 percent of the arteries cleared by angioplasty and propped open with standard metal mesh stents became re-clogged with scar tissue, forcing patients to undergo repeat angioplasties – or, in some cases, the bypass surgery they hoped to avoid.

Hoping to overcome this problem, researchers developed a coated stent that drastically reduces the rate of re-clogging, called restenosis, after angioplasty. These stents are coated with medications that help to prevent the buildup of scar tissue that may eventually impede blood flow.

The FDA is expected to approve the Cypher stent before April. The Cypher is coated with the antibiotic rapamycin (Sirolimus), which has been used previously to prevent rejection in kidney transplants. In a couple of European studies, none of the cardiac patients given Sirolimus-coated stents developed restenosis. In a US study of more than 1,100 patients, the coated stent reduced re-clogging inside the stent by 91 percent.

Surgery

Among the millions of people who undergo surgery each year, up to three percent will end up with infections around their stitches – but that risk may soon decline. Last month, the FDA approved the first suture coated with an antibacterial drug.

The drug, Triclosan, fights such germs as staphylococcus aureus and staphylococcus epidermis, as well as antibiotic-resistant staphylococcus, which are responsible for many of the hospital-acquired infections that patients develop each year. Many of these germs can live harmlessly on the patient’s skin, but when they catch a ride into the body through the stitches holding together a surgical wound, they can wreak havoc.

Majority of these infections occur in the area directly surrounding the stitches. Once the bacteria get into the surgical site, they begin rapidly multiplying, sometimes invading deeper tissues and entering the blood stream.

The Vicryl Plus Antibacterial Suture doesn’t kill the bacteria. Instead, it creates an unfriendly environment so that they won’t multiply and form colonies on the stitches for at least 48 hours, when most surgical site infections take hold. The suture is absorbable.

More To Come

In other developments, gene therapy and cloning will continue to make headlines with their promise of dramatic advances in the treatment of disease and reproductive technology.

So, as in the past, some of the most important medical news today involve prescription drugs – and this is especially true this year. Patients will definitely have more drug therapy options in 2003!