PHARMACY

Data from Qnexa study presented at World Diabetes Congress

BY Allison Cerra

MOUNTAIN VIEW, Calif. — Obese diabetes patients could experience weight loss when taking Vivus’ anti-obesity drug, according to an oral presentation at the International Diabetes Federation’s World Diabetes Congress in Dubai.

The presentation, given by Nancy Bohannon — director of clinical research at the cardiovascular risk reduction program at St Luke’s Hospital in San Francisco and scientific advisory board member at Vivus — said that when analyzing a subset of patients enrolled in the CONQUER study, 147 of them had diabetes and a body mass index greater than 35. Among this population, 33% experienced excess weight loss when taking Vivus’ Qnexa over a 56-week treatment period, compared with 7.4% of patients in the placebo group. The weight loss also was highly correlated to improvements in glycemic parameters, including fasting glucose, fasting insulin and hemoglobin A1C.

Additionally, normalization of glucose levels and withdrawal of all antidiabetic medications occurred in 15% of patients treated with full dose Qnexa, compared with 2% that were treated with placebo.

Excess weight loss typically is reported in patients who have undergone weight-loss surgery, Bohannon said.

"Multiple options are needed to address the parallel epidemics of diabetes and obesity, and Qnexa could be a potential nonsurgical approach to both treat obesity and improve glycemic control in obese diabetic patients," she said.

The safety profile in this subpopulation, based on reported adverse events, is consistent with that seen in the whole study population, the presentation noted. The most common adverse events seen were constipation, upper respiratory infection and tingling.


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Drug shows improvement in symptoms of autism in children

BY Alaric DeArment

RYE, N.Y. — A drug in late-stage clinical trials appears to treat the symptoms of autism, the drug’s developer said Wednesday.

Curemark announced results of the phase-3 trial of CM-AT in children ages 3 to 8 years. The company said the drug had a statistically significant effect on symptoms of autism compared with placebo. The Food and Drug Administration has granted the drug fast-track status, which it does for investigational drugs to treat serious or life-threatening conditions that may address unmet medical needs.

"We are extremely pleased with the results of our trial," Curemark CEO Joan Fallon said. "We wish to thank all the children and their parents who participated in the study and look forward to a full review of the data by the FDA."


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FDA modifies REMS for two drugs to treat low platelet counts

BY Alaric DeArment

SILVER SPRING, Md. — Prescribers, patients and specialty care centers no longer will be required to enroll in safety monitoring programs for two drugs used to treat low platelet counts, following changes to their risk evaluation and mitigation strategies.

The Food and Drug Administration announced changes to the REMS programs for Amgen’s Nplate (romiplostim) and GlaxoSmithKline’s Promacta (eltrombopag), two drugs approved in 2008 to treat low platelet counts in patients with chronic immune thrombocytopenia, who have not responded to other drugs or to the removal of their spleens. In addition, pharmacists will no longer have to enroll in the Promacta CARES safety monitoring program or verify prescriber and patient enrollment to dispense the drug. Meanwhile, both drugs’ REMS programs will include a communication plan to inform healthcare professionals about the changes and the drugs’ safety risks.

The FDA said that some of the requirements of the drugs’ REMS programs were no longer necessary to ensure that their benefits outweighed their risks.

"REMS continue to be vital tools for the agency to employ as we work with companies to address the serious risks associated with drugs and monitor their appropriate and safe use in various healthcare settings," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "The agency remains committed to exercising a flexible and responsible regulatory approach that ensures REMS programs are being effectively and efficiently used and not resulting in an unnecessary burden on healthcare professionals and patients."


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