Hormone deemed effective in male birth-control pill
TORRANCE, Calif. According to published reports, one of the two government-funded research centers in the U.S. for male contraceptives has discovered hormone pills that block sperm production in men and has found them to be safe and reversible.
The hormone combination that proved most successful halts testosterone production in the testicles, but fakes the body into believing that testosterone levels are the same, according to the study. The progestin, typically a female hormone, speeds the process and improves the effectiveness of the drug, research shows. The hormones can be taken in a pill or injection form.
As with female birth control, the male contraceptives don’t prevent sexually transmitted disease. But they have proven as effective as female pills in preventing pregnancy, according to the study.
The next goal is to find pharmaceutical companies that want to conduct final development of the drug, but so far companies have been unwillingly to take part because of the regulatory requirement involved in manufacturing a contraceptive.
Amgen, Wyeth revise labeling for Enbrel
PHILADELPHIA and THOUSAND OAKS, Calif. Amgen and Wyeth Pharmaceuticals have informed health care professionals of revisions to prescribing information for their rheumatoid arthritis and psoriasis medication Enbrel.
The revisions include a boxed warning about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel.
Infections have included bacterial sepsis and tuberculosis. The adverse reactions section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel.
FDA approves Advair for wider use with COPD patients
WASHINGTON The Food and Drug Administration has approved GlaxoSmithKline’s asthma drug Advair to be used more widely to treat patients with chronic obstructive pulmonary disease, according to published reports. The drug had been approved to prevent wheezing and control other symptoms in COPD patients.
GSK’s approval comes the same day as rival AstraZeneca said it also was seeking FDA approval to sell its drug Symbicort for COPD.
COPD, an often-fatal lung condition with no cure, is a major market with more than 12 million Americans suffering from the disease, and another 12 million who are likely not diagnosed, according to the National Institutes of Health.
The FDA’s approval allows GSK to promote its product to COPD patients who experience flare-ups of the disease, which includes emphysema and chronic bronchitis.