Zacks
0
All posts from Zacks
Zacks in Our Research. Your Success.,

Shire's ADHD Drug Meets Primary Endpoint in Phase III Trial

Shire plc SHPG announced positive top-line results from a phase III trial, SHP465-305, on its pipeline candidate – SHP465.

The four-week phase, randomized, double-blind, multi-center, placebo-controlled study evaluated the safety and efficacy of SHP465 in children and adolescents aged 6–17 years suffering from attention-deficit/hyperactivity disorder (ADHD).

We note that Shire suffered a setback in Oct 2014, when the FDA had informed the company that it requires additional pediatric data on the candidate in order to approve its regulatory application. Thereafter, Shire has reached an agreement with the agency on a clear regulatory path for SHP465.

The study was conducted as per the FDA’s requirement to evaluate the safety and efficacy of SHP465 in children and adolescents prior to filing a Class 2 resubmission of the drug for FDA approval.

Data from the study showed that SHP465 had met the primary endpoint as it showed an improvement in ADHD symptoms in children and adolescents. SHP465, administered as a daily morning dose, was superior to placebo on the change from baseline in ADHD-RS-IV (ADHD rating scale) total score. The study also met its secondary endpoint.

Shire has assimilated data from 15 clinical trials evaluating SHP465 in more than 1,100 studies. Consequently, the company plans to include these study results in its existing SHP465 data set for a Class 2 resubmission with the FDA for an approval of the drug for the treatment of ADHD upon completion of the ongoing pharmacokinetic study and additional safety and efficacy phase III trials later in 2016. Shire remains on track to file for a potential launch of SHP465 in the second half of 2017 in the U.S.

Shire currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Novo Nordisk A/S NVO, Eli Lilly and Company LLY and Johnson & Johnson JNJ. All three stocks carry a Zacks Rank #2 (Buy).

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. http://woas.zacks.com/adv/7stock_report.pdf?ADID=ZACKS_PFP_7... blog">Click to get this free report >>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
SHIRE PLC-ADR (SHPG): Free Stock Analysis Report
 
LILLY ELI & CO (LLY): Free Stock Analysis Report
 
NOVO-NORDISK AS (NVO): Free Stock Analysis Report
 
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research