FDA approves Vyvanse for adults with ADHD
PHILADELPHIA — The Food and Drug Administration has approved a drug made by Shire for attention deficit hyperactivity disorder, the company said Tuesday.
Shire announced the FDA approval of Vyvanse (lisdexamfetamine dimesylate) capsules as a maintenance treatment for adults with ADHD. The drug already was approved for use in children and was approved for treating ADHD in adults in 2008.
The company said the approval was based on a clinical trial that showed more ADHD patients controlling their symptoms with Vyvanse than with placebo.
Reps. seek sponsors for MTM bill
NEW YORK — Two members of Congress are looking for co-sponsors for a bill that would strengthen the medication therapy management benefit in the Medicare prescription drug program.
Last year, Rep. Mike Ross, D-Ala.; and Cathy McMorris Rodgers, R-Wash., introduced H.R. 891, the Medication Therapy Management Benefits Act, which would allow elderly people with at least one chronic condition access to Medicare Part D coverage for MTM. Currently, only those with multiple conditions are eligible.
In late January, Ross and Rodgers sent a letter to other members of the House of Representatives seeking co-sponsors for the bill. "There is significant evidence that MTM improves care and saves money," the two wrote, mentioning that CareFirst BlueCross BlueShield of Maryland found in a study last year that for every dollar spent on MTM, $10 was saved in avoided healthcare costs.
The letter drew praise from the National Association of Chain Drug Stores. "Pharmacist-administered MTM services allow a clinically trained pharmacist to conduct one-to-one counseling sessions with patients to help ensure the best combinations of medicines are taken properly," NACDS president and CEO Steve Anderson said. "MTM is just one of many services provided by pharmacists that demonstrate the unsurpassed value of community pharmacy. These services can improve health and reduce healthcare costs across the board."
Investigational Merck drug ‘significantly’ reduces cardiovascular death
WHITEHOUSE STATION, N.J. — A drug under development by Merck "significantly" reduced the risk of heart attack, stroke and cardiovascular death in patients, according to clinical trial results announced Tuesday.
Merck announced the release of data from the 26,449-patient "TRA-2P" study of vorapaxar, a drug designed to prevent clotting of the blood. The drug also showed a significant increase in bleeding, including within the skull, known as intracranial hemorrhage, though there was a lower risk of intracranial hemorrhage in patients without a history of stroke.
"In developing vorapaxar, Merck and our scientific collaborators set a very high bar — would the addition of vorapaxar to standard of care provide incremental benefit in preventing clots?" Merck Research Labs president Peter Kim said. "We are pleased that TRA-2P met its primary endpoint, and we look forward to discussing the results with the scientific community."
Results of the trial will be presented at the American College of Cardiology Scientific Sessions next month.