Shionogi gets FDA approval for Kapvay
FLORHAM PARK, N.J. The Food and Drug Administration has approved a nonstimulant drug for treating attention deficit hyperactivity disorder.
Shionogi announced Monday the approval of Kapvay (clonidine hydrochloride), an extended-release drug for treating ADHD in children and adolescents ages 6 to 17 years. The company said Kapvay was the only formulation of clonidine hydrochloride approved for treating ADHD and the first ADHD treatment approved for use as an add-on therapy to stimulant drugs.
“The FDA approval of Kapvay represents an exciting milestone in the field of ADHD,” Shionogi chief medical officer Donald Manning said. “We look forward to providing this important, beneficial treatment for ADHD to patients, both as monotherapy and add-on therapy to stimulants.”
Walmart, Humana unveil new Medicare Part D prescription drug offering
BENTONVILLE , Ark. (Oct. 1) Walmart and Humana on Friday unveiled a new Medicare Part D prescription drug offering designed to help both companies gain market share and save money for those enrolled in the program.
Co-branded as the Humana Walmart-Preferred Rx Plan, the program involves a $14.80 monthly premium that is less than half the weighted 2010 national average, generic drug co-payments as low as $2 at Walmart pharmacies and no co-payments for select generics filled via Humana’s RightSource home-delivery service. Humana and Walmart said the program has the potential to save Medicare Part D enrollees as much as $450 annually.
“People are more likely to take the medications prescribed for them when they can afford those medications,” said William Fleming, PharmD, VP Humana Pharmacy Solutions. “And adhering to prescription-drug regimens can enable people to be healthier and prevent future illness. At Humana, we believe that this prevention helps people live healthier lives and achieve lifelong well-being.”
John Agwunobi, M.D., president of Walmart’s Health and Wellness division said Walmart is uniquely qualified to help lower the cost of prescriptions because it is the world’s largest retailer.
“We know every dollar counts, especially when you live on a fixed income. We believe no one should have to choose between buying their groceries or their medications,” Agwunobi said.
He called the program an example of Walmart’s commitment to help people save money so they can live better.
It is also an example of how Walmart can bring more shoppers to its store. There are an estimated 18 million people enrolled in the Medicare Part D program, but that figure is forecast to grow to 26 million by 2015. Open enrollment in the program begins Nov. 15 and continues through the end of the year, and Humana and Walmart are undertaking an extensive media relations and marketing campaign to drive awareness and education. A key element involves kiosks in some 3,000 stores which will occasionally be staffed by Humana representatives.
Teva unveils mid-stage clinical trial results for MS drug
JERUSALEM Teva Pharmaceutical Industries and Active Biotech announced promising results from a mid-stage trial of laquinimod, a once-daily oral treatment for relapsing-remitting multiple sclerosis.
The companies released results of a phase-2 extension study of the drug indicating that it was safe for use in patients, but also reduced lesions that are a marker of disease activity by 52%. In addition, the study indicated that the drug reduced relapses of the disease and did not show evidence of suppression of the immune system. Results of the study were published online in the journal Multiple Sclerosis.
The two companies expect to see results of two phase-3 trials of the drug next year. The Food and Drug Administration gave fast-track designation to the drug in February 2009.