FDA cleared Shire’s Vyvanse® (lisdexamfetamine dimesylate) capsules as a maintenance therapy for adult patients with attention-deficit/hyperactivity disorder (ADHD). Approval was based on data from a Phase IV placebo-controlled withdrawal design study in 123 adult patients who met DSM-IV-TR criteria for ADHD. Participants had all previously been receiving Vyvanse for at least six months, and demonstrated treatment response according to ADHD Rating Scale IV, and Clinical Global I impressions-Severity (CGI-S) scores.
The resulting data showed that significantly more patients who remained on Vyvanse therapy maintained ADHD symptom control than those switched to placebo. Specifically, 75% of patients switched to placebo, but only 8.9% of those remaining on Vyvanse therapy exhibited symptom relapse according to ADHD-RS-IV and CGI-S scores of symptom severity. “Vyvanse is the first medicine both proven to work and approved to maintain efficacy in adults with ADHD,” comments Jeffrey Jonas, M.D., svp for R&D at Shire’s specialty pharmaceuticals and regenerative medicines businesses.
Vyvanse was introduced in the U.S. in 2007 for the treatment of ADHD in children aged 6–12 years, and was cleared in 2008 and 2010 for the treatment of adults, and adolescents, respectively. The drug is Shire’s top-selling pharmaceutical, achieving sales of $199.7 million in the three months to September 30 2011, up 32% on the same period in 2010. Another of Shire’s ADHD drugs, Adderall XR, is its second biggest selling pharmaceutical, which made sales of $149.9 million in Q3 2011, up 50% on Q3 2010.
Lisdexamfetamine dimesylate has yet to be approved in Europe, but in October 2011 Shire reported positive top line results from the first European Phase III study evaluating the drug as a once-daily treatment for children and adolescents aged 6 to 17 years with ADHD. The firm is separately developing Vyvanse for the treatment of major depressive disorder (MDD). In December 2011 positive data was reported from a Phase II trial evaluating the drug as adjunctive therapy to primary antidepressant treatment in adults with partial or full remission of recurrent MDD and significant, persistent cognitive impairments.