Navigation Links
VYVANSE trial in adult ADHD demonstrated significant efficacy within 1 week of daily treatment
Date:10/25/2007

BOSTON October 25, 2007 Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, today announced the results of a study which demonstrated that adults with Attention Deficit Hyperactivity Disorder (ADHD) experienced significant improvements in ADHD symptom control within one week of treatment with once-daily VYVANSE (lisdexamfetamine dimesylate), the first prodrug stimulant. Findings from this phase III pivotal trial were presented today at a national psychiatric meeting in Boston, Mass.

Adults with ADHD may experience significant impairments in their ability to focus, and organize and complete tasks, which could affect their work, family life and personal relationships, said Lenard A. Adler, M.D., lead researcher in this study and director of the Adult ADHD Program at New York University School of Medicine and author of Scattered Minds: Help and Hope for Adults with ADHD. The results of this study demonstrated that VYVANSE significantly improved the core symptoms of ADHD in adult study patients.

Results of Phase III Pivotal Trial

In this double-blind, placebo-controlled, four-week study with dose escalations in 414 adults aged 18 to 55 years, treatment with VYVANSE at all doses studied (30 mg, 50 mg, 70 mg) was significantly more effective than placebo and improvements were observed in the first week of the study.

All doses of VYVANSE showed significant improvements in the average change in ADHD Rating Scale (ADHD-RS-IV) scores, as measured from the studys start to end, the primary endpoint of this study. ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD and for assessing their response to treatment. The scale, which contains 18 items, is based on the ADHD diagnostic criteria as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, a publication of the American Psychiatric Association.

VYVANSE provided a significant reduction in ADHD-RS-IV scores starting at week one that were observed throughout the full treatment period. At endpoint, VYVANSE provided a significant reduction in ADHD-RS-IV scores ranging from 16.2 to 18.6 points.

Investigators also measured the efficacy of VYVANSE with the Clinical Global Impressions-Improvement (CGI-I) scale, a standard assessment used to rate the severity of a patients illness and improvement over time. The study found that the percentage of subjects taking VYVANSE rated improved on the CGI-I scale ranged from 57 to 61 percent across all doses and was significantly greater than placebo.

The study showed there were no statistically significant differences among the groups for total score of Pittsburgh Sleep Quality Index (PSQI) at endpoint with all groups showing a slight decrease in the PSQI total score at endpoint. The PSQI is a self-rated questionnaire that assesses sleep quality and disturbances over a one-month time interval.

Adverse events reported in this study were generally mild to moderate and included dry mouth (26 percent), decreased appetite (27 percent) and insomnia (19 percent).

VYVANSE is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine. The pharmacokinetic profile of VYVANSE is inherent to its chemical prodrug nature and alterations in gastric pH and gastrointestinal motility do not affect its absorption.

A supplemental New Drug Application (sNDA) for VYVANSE for the treatment of ADHD in adults is currently under review by the U.S. Food and Drug Administration (FDA). VYVANSE is currently approved in the United States for the treatment of ADHD in children aged 6 to 12 years.


'/>"/>

Contact: Jacelyn Seng
212-601-8385
Porter Novelli
Source:Eurekalert

Related medicine news :

1. VYVANSE(TM) Drug for the Treatment of ADHD in Adults
2. Man against HIV – new vaccine ready for human trials
3. FDA approves Phase 0 trial which tests experimental drugs on humans
4. Male contraceptive in trial
5. How do patients benefit of clinical trials
6. Glenmark’s new molecule to go through trial
7. Clinical trials need to be more frank
8. First head-to-head trials of once weekly Fosamax and Actonel therapies
9. Hormone Replacement Therapy increases the risk of endometrial cancer
10. Atrial fibrillation predicts for acute ischaemic stroke
11. Spray on contraceptive clears Phase I trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Software Development, has been awarded a contract by the Center for Medicare and ... aims to accelerate the enterprise use of Agile methodologies in a consistent and ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San Francisco ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are estimated ... in breathing. Oral appliances can offer significant relief to about 75 percent of ...
(Date:10/12/2017)... Bethesda, MD (PRWEB) , ... October 12, 2017 , ... ... Award of Excellence to Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s ... 4 – 8. , In honor of Morris F. Collen, a pioneer in the ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a ... of a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners ... October 11, 2017. , The annual award competition recognizes editorial and design excellence across ...
Breaking Medicine News(10 mins):
(Date:9/23/2017)... , Sept. 22, 2017 Janssen Biotech, Inc. ... response letter from the U.S. Food and Drug Administration ... of sirukumab for the treatment of moderately to severely ... additional clinical data are needed to further evaluate the ... severely active RA. ...
(Date:9/22/2017)... -- AVACEN Medical (AVACEN) announced that its CE-Marked AVACEN ... with the widespread pain associated with fibromyalgia in the ... Essex, England commented, "I had difficulty ... sleep at all, tremendous pain, with every movement sending ... AVACEN 100] enough, how this has and is helping ...
(Date:9/19/2017)... LOUISVILLE, Ky. , Sept. 19, 2017   ZirMed ... and predictive analytics, today announced that it has been ranked ... the Black Book™ Rankings 2017 User Survey. ZirMed ... software solution for large hospitals and medical centers over 200 ... in Black Book,s healthcare technology user survey history. ...
Breaking Medicine Technology: