Study: Diabetes medication may help decrease BMI in obese adolescents
NEW YORK A new study published in the February issue of Archives of Pediatrics & Adolescent Medicine found that a medication used to treat Type 2 diabetes appears to cause a small but significant decrease in body mass index in nondiabetic obese adolescents when combined with a lifestyle intervention program.
Darrell M. Wilson, M.D., of Stanford University and the Lucile S. Packard Children’s Hospital of Stanford, Calif., and colleagues in the Glaser Pediatric Research Network Obesity Study Group randomly assigned 77 obese adolescents (ages 13 to 18 years) to a lifestyle intervention program (consisting of physical activity and diet) and either one daily dose of metformin XR (2,000 milligrams) (39 patients) or placebo (38 patients) for 48 weeks. Participants were monitored for an additional 48 weeks.
“Metformin XR had a small but statistically significant impact on BMI over the initial 52 weeks of the study,” the authors wrote, adding that the average BMI increased by 0.2 in the placebo group and decreased by 0.9 in the metformin XR group. “The BMI difference between the groups persisted for 12 to 24 weeks after cessation of study drug. Thereafter, the mean [average] BMI in the metformin group increased toward that in the control group.
“Metformin was safe and tolerated in this population. These results indicate that metformin may have an important role in the treatment of adolescent obesity,” the authors added. “Longer-term studies will be needed to define the effects of metformin treatment on obesity-related disease risk in this population.”
Watson to become commercial partner for emergency contraceptive
MORRISTOWN, N.J. Watson Pharmaceuticals and HRA Pharma have signed a deal whereby Watson will become the commercial partner for an emergency contraceptive undergoing regulatory review by the Food and Drug Administration, Watson announced Monday.
Watson and HRA signed the agreement for ulipristal acetate, also known as UPA, which HRA has marketed in Europe under the EllaOne brand since October 2009. According to data published in a recent issue of medical journal The Lancet comparing the drug with levonorgestrel in 1,696 women in the United States, Ireland and the United Kingdom, UPA provides emergency contraception effectively for up to five days after unprotected sex. Duramed Pharmaceuticals markets levonorgestrel under the Plan B brand, and Watson markets a generic version.
Under the terms of the agreement, Watson will make milestone payments to HRA and royalties on U.S. sales while taking responsibility for commercialization and marketing expenses.
“The opportunity to collaborate with HRA Pharma on the U.S. commercialization of UPA fits nicely within our broader strategy to expand our emerging position in women’s health care and to provide women with a vast array of safe, effective treatment options in contraception as well as other important therapeutic areas,” Watson EVP global brands Fred Wilkinson said. “The published clinical results are significant, and we are optimistic about the prospects of providing U.S. women with a new emergency contraceptive option.”
FDA approves expanded use of breast cancer drug
PHILADELPHIA The Food and Drug Administration has given an additional approval to a breast cancer drug made by GlaxoSmithKline, GSK announced Friday.
The FDA approved Tykerb (lapatinib) combined with Novartis’ Femara (letrozole) as an all-oral, first-line treatment for postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 protein. HER2 is involved in normal cell growth, but can contribute to cancer when found on cancer cells, and between 25% and 30% of breast cancers overexpress the protein; 60% to 70% of breast cancer cases in the United States and Europe are hormone receptor-positive.
“This combination of Tykerb plus Femara is an example of advancing science and improving patient care,” GSK Oncology research and development SVP Paolo Paoletti said. “This regimen attacks two specific receptors that drive cancer growth. Women battling this disease now have the opportunity to delay the use of traditional cytotoxic chemotherapy, which is an exciting possibility for them.”
Tykerb already had approval as a combination with Roche’s Xeloda (capecitabine) chemotherapy in patients with HER2 advanced or metastatic breast cancer who had received prior therapy with anthracycline chemotherapy and Genentech’s Herceptin (trastuzumab). So far, however, Tykerb combined with Femara — or any other drug belonging to Femara’s class, known as aromatase inhibitors — has not been compared with a treatment regimen based on Herceptin and chemotherapy.