2/7/2012 12:44 PM ET
(RTTNews) - Shire plc (SHP.L: News ,SHPGY: News ) Tuesday announced that the US Food and Drug Administration approved the prescription medication Vyvanse (lisdexamfetamine dimesylate) Capsules, as a maintenance treatment for adults with ADHD. The previous approval was for adolescents up to age 17.
Shire said Vyvanse is the first medication both proven to work and approved for maintenance treatment in adults with Attention-Deficit/Hyperactivity Disorder or ADHD.
The approval is based on results from a randomized withdrawal study designed to evaluate the efficacy of Vyvanse in adults (aged 18 to 55 years) who were receiving treatment with Vyvanse for a minimum of 6 months prior to enrolling in the study.
On the primary efficacy measure, significantly fewer patients met criteria for symptom relapse with Vyvanse versus placebo at end point of the randomized withdrawal phase.
Shire said 8.9 percent of Vyvanse-treated patients demonstrated relapse of symptoms compared with 75 percent for placebo at end point during the six-week randomized double-blind withdrawal phase of the study.
This new approval adds to the indication for Vyvanse as a treatment for ADHD in patients ages 6 and above.
Matthew Brams, MD, Principal Investigator, said," This study showed that in patients with ADHD who were stable on Vyvanse for 6 months, 91% randomized to receive Vyvanse continued to maintain symptom control compared with 25% taking placebo."
In a randomized withdrawal design, patients who respond to a treatment are randomized to continue receiving that treatment or placebo. Utilizing the proportion of patients experiencing symptom relapse as a primary outcome, this type of study in patients with ADHD can be used to demonstrate long-term efficacy in lieu of conducting a long-term placebo-controlled, parallel-group study.
The utility of this design is that the period of placebo exposure, with the potential for worsening of ADHD symptoms, is relatively short.
Jeffrey Jonas, senior vice president of Research and Development for Dublin, Ireland-based Shire's Specialty Pharmaceuticals and Regenerative Medicine businesses, said," Data from this study and the resulting approval illustrate that Vyvanse can help adults with ADHD maintain symptom control. Vyvanse is the first medicine both proven to work and approved to maintain efficacy in adults with ADHD."
Vyvanse, which was introduced in the United States in July 2007 for the treatment of ADHD in children ages 6 to 12 years, approved in April 2008 to treat ADHD in adults, and approved in November 2010 to treat ADHD in adolescents ages 13 to 17, is currently available in six once-daily dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.
 | | To receive FREE breaking news email alerts for Shire plc and others in your portfolio |
|
1
2
Next Page