New Osteoporosis Treatment Shows Early Signs of Success
It’s a long road between phase 2 clinical trials (about the halfway point in the testing of a new drug) and bringing a new drug to the marketplace. For that reason, little is rarely said publicly, or in the media, about phase 2 researchers.
However, an exception appears to be permissible in the case of a recent announcement on phase 2 data from a study on the treatment of osteoporosis. Researchers reported last month that a biologically engineered hormone, called ALX1-11, may be the first to generate new bone growth in women with the bone-thinning disease. The study of 217 Canadian and U.S. women increased bone density in the spine by 7%, a significant increase. The data were reported at a meeting of the American Society for Bone and Mineral Research.
The drug will move into phase 3 clinical trials early next year to see if the regenerated bone is as strong as bone in its original composition. If it proves to be safe and effective, it still would not be available to consumers until 2000 at least. Still, Dr. Robert Lindsay, president of the National Osteoporosis Foundation, called the results “a promising novel approach,” particularly for women with spinal osteoporosis or severe disease in which bone growth must be achieved rapidly. ALX1-11, which is made by Allelix Biopharmaceuticals, is identical to the natural human parathyroid hormone, which regulates calcium metabolism.
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Celexa’s popularity grows: Celexa, the bestselling antidepressant in Europe, is attracting some interest in this country, six months after its introduction in the U.S.
Celexa is a selective serotonin reuptake inhibitor that is more popular than even Prozac in many other countries. The drug, marketed by Forest Laboratories and the Parke-Davis division of Warner-Lambert Co., received FDA approval in July. It’s currently the only SSRI with an increasing share of new prescriptions.
The medication has captured interest because it has few side effects (the major ones are nausea, dry mouth and sleepiness) and has few interactions with other medications. Unlike some of the other SSRIs, Celexa does not appear to cause the weight gain that sometimes leads patients to stop using antidepressants.
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Emergency contraceptives: Some heavy hitters in the world of reproductive health care have published an argument for making emergency contraceptives available over the counter. Emergency contraceptives are small doses of ordinary birth-control pills that can prevent pregnancy if taken up to 72 hours after unprotected intercourse. The first specially packaged emergency contraceptive product, Prevens, was recently approved by the Food and Drug Administration.
According to a recent report from the Journal of the American Medical Women’s Assn., emergency contraceptives “can safely be marketed over the counter.” The authors of the article, which include Princeton researcher James Trussell and Dr. Felicia H. Stewart of the Kaiser Family Foundation, describe the control of emergency contraceptives as “paternalistic.”
“Professional assistance is not necessary since the woman diagnoses her own need for the pills and takes them herself,” they write. “ECPs do not need to be adjusted for the individual woman and pose no potential threat of overdose or addiction. There are no contraindications except confirmed pregnancy [in which case the therapy will not work], and monitoring is not necessary.”
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Cancer risk downgraded: Women who take ovulation-inducing medications to try to conceive are not putting themselves at any greater risk of developing ovarian cancer, according to a study in the December issue of Fertility and Sterility.
Previous research had hinted at an increase of ovarian cancer among women who used fertility drugs. But the new study, from Denmark, compared 231 women with ovarian cancer to 1,721 healthy women. It found that the women who had taken ovulation drugs had no increased risk of cancer. There does seem to be a link, however, between women who are infertile and a higher risk of ovarian cancer for reasons that are unclear. Taking the ovulation drugs, however, appears to have nothing to do with the risk. “This study is one more piece of evidence that should help alleviate some fears that couples may have about their fertility treatment and the risk of ovarian cancer,” said Dr. J. Benjamin Younger, executive director of the American Society for Reproductive Medicine.
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Pregnancy and epilepsy: Pregnant women who take anti-epileptic drugs can assist researchers by calling the AED Pregnancy Registry at Massachusetts General Hospital. Doctors there are trying to determine whether exposure to medications is associated with birth defects or effects on growth of the fetus. AEDs are typically prescribed to control seizures or to treat pain, anxiety, depression and migraine headaches. There is little information, however, on the safety of AEDs during pregnancy. Women can call (888) 233-2334 to register information about their pregnancy and birth outcome.
