This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

Vyvanse® (lisdexamfetamine Dimesylate) Capsules, (CII) Now Approved In The US For Maintenance Treatment In Children And Adolescents With ADHD

To evaluate the efficacy of Vyvanse for maintenance treatment in children and adolescents with ADHD, Shire elected to conduct a double-blind, placebo-controlled, randomized withdrawal clinical trial. In this design, patients who respond to a treatment are randomized to continue receiving that treatment or placebo. Using 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.

The double-blind, placebo-controlled, randomized withdrawal study was conducted in 276 children and adolescents aged 6 to 17 with ADHD. Of these patients, 236 participated in a preceding study and 40 directly enrolled. The study consisted of 4 phases:

  • 4-week, open-label, dose-optimization phase in which patients received Vyvanse 30 mg/day, 50 mg/day, or 70 mg/day. Eligible subjects started on Vyvanse 30 mg/day and could be titrated in weekly increments of 20 mg until an optimal dose was reached (up to a maximum of 70 mg/day)
  • 20-week, open-label, maintenance phase
  • 2-week, open-label, fixed-dose phase in which patients were discontinued if they required further dose adjustments, experienced unacceptable tolerability, or had an Attention-Deficit/Hyperactivity Disorder Rating Scale, Version IV (ADHD-RS-IV) total score >22 or Clinical Global Impression Severity (CGI-S) score ≥3. Patients who maintained treatment response entered the randomized withdrawal phase.
  • 6-week, double-blind, randomized withdrawal phase in which patients either received ongoing treatment with the same dose of Vyvanse (N=78) or were switched to placebo (N=79).

The primary outcome measure was the proportion of patients who met criteria for relapse of ADHD symptoms (treatment failure) at end point during the double-blind, randomized withdrawal phase. The end point measurement was defined as the last post-randomization treatment week at which a valid ADHD-RS Total Score and CGI-S were observed. Treatment failure was defined as a ≥50% increase (worsening) in the ADHD-RS Total Score and a ≥2-point increase in the CGI-S score compared to scores at entry into the double-blind, randomized withdrawal phase. On the primary end point, significantly fewer patients met criteria for symptom relapse with Vyvanse (15.8%) versus placebo (67.5%) ( P<.001).

During the 26-week open-label phase, 12 patients (4.3%) reported serious adverse events (SAEs), and 45 patients (16.3%) reported treatment-emergent adverse events (TEAEs) that resulted in Vyvanse discontinuation. During the randomized withdrawal phase, no SAEs were reported in the Vyvanse group, no patients in the Vyvanse group discontinued due to a TEAE, and 1 patient in the placebo group discontinued due to a TEAE. In addition, 39.7% (31/78) of patients receiving Vyvanse and 25.3% (20/79) on placebo reported TEAEs. The most common TEAEs (≥2%) reported in the Vyvanse treatment group during the randomized withdrawal phase included nasopharyngitis, headache, abdominal pain upper, oropharyngeal pain, decreased appetite, vomiting, weight decrease, abdominal pain, accidental overdose, aggression, cough, nausea and rhinitis.

2 of 7

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,214.42 -10.15 -0.06%
S&P 500 2,110.74 -3.12 -0.15%
NASDAQ 4,987.89 +20.7530 0.42%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs