OREANDA-NEWS. Shire plc (LSE: SHP, NASDAQ: SHPG) today announced positive topline results from a four-week randomized, double-blind, multicenter, parallel-group, placebo-controlled, forced-dose titration, efficacy and safety study, SHP465-306, in 275 adults aged 18-55 years with Attention-Deficit/Hyperactivity Disorder (ADHD). SHP465 (triple-bead mixed amphetamine salts - MAS) is an investigational oral stimulant medication being evaluated in the U.S. as a potential treatment for ADHD, a therapeutic area with significant need for additional treatment options.

The primary efficacy analysis of study 306 showed that SHP465 12.5mg and 37.5mg, both administered as a daily morning dose, were superior to placebo with respect to the change from baseline on a clinically administered ADHD rating scale (ADHD-RS) total score, with Least Squares mean differences from placebo at Week 4 of -8.1 (95% CI: -11.7 to -4.4, p<0.001) for 12.5mg, and -13.3 (95% CI: -17.0 to -9.6, p<0.001) for 37.5mg. SHP465 12.5mg and 37.5mg doses were also significantly better than placebo on the key secondary efficacy analysis of the clinical global impression improvement scale (CGI-I), at Week 4 of -0.8 (95% CI: -1.1 to -0.4, p<0.001) for 12.5mg, and -1.2 (95% CI: -1.6 to -0.9, p<0.001), suggesting a marked clinical improvement in patients’ global functioning. The CGI-I is a standardized assessment tool that allows clinicians to rate the severity of ADHD illness, change over time and efficacy of medication.

Treatment-emergent adverse events ≥ 5% for either dose of SHP465 were decreased appetite, dry mouth, insomnia, headache, anxiety, irritability and bruxism. Adverse events were generally mild to moderate in severity and similar to those observed in previous SHP465 studies and with other amphetamine compounds.

Matthew Brams, M.D., Clinical Assistant Professor at Baylor College of Medicine and principal investigator for study 306, added: “ADHD affects adults in multiple ways and, therefore, physicians need additional treatment options. Based upon this study’s findings, and pending the U.S. FDA’s review, SHP465 may provide a promising treatment option for physicians and patients alike.”

“Shire has been working to fully understand the different needs of adult patients with ADHD so we can help physicians and their patients optimally manage the disorder,” said Philip J. Vickers, Ph.D., Head of Research and Development at Shire. “We are excited that SHP465, when taking into account the broader clinical development program and multiple dosing strengths, has the potential to benefit adult patients with ADHD.”

Shire plans to file a Class 2 Resubmission of the New Drug Application (NDA) with the U.S. Food and Drug Administration by the end of 2016; the program is on track for potential U.S. approval in the second half of 2017.

Overall Robust SHP465 Clinical Development Program to Support Class 2 Resubmission

Including study 306, Shire now has a robust database of 16 clinical studies evaluating more than 1,600 subjects in the SHP465 program.

Along with the pharmacokinetic study completed earlier this year, Shire plans to add these study results to its existing SHP465 data set to submit a Class 2 resubmission for FDA approval of the medicine for the treatment of ADHD.

Protection for Shire’s ADHD Franchise Extends to 2029

There are patents supporting Shire’s overall ADHD franchise in the U.S. that extend to 2029. With a launch planned for the second half of 2017, Shire expects that SHP465, following potential FDA approval, will have three years of Hatch-Waxman exclusivity and at least three patents listed in the FDA Orange Book expiring as late as May 2029.

About ADHD in Adults

Attention-Deficit/Hyperactivity Disorder is a neurodevelopmental disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development and is inconsistent with developmental level.

An estimated 4.4% of adults have ADHD in the U.S. When applied to the full U.S. adult population aged 18 and over, approximately 10.5 million adults are estimated to have ADHD in the U.S.

The specific etiology of ADHD is unknown. The diagnosis is made utilizing criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5®) or International Classification of Diseases, 10th revision (ICD-10). Only a trained healthcare professional can evaluate and diagnose ADHD.
Although there is no cure for ADHD, there are accepted treatments that have been demonstrated to improve symptoms. Standard treatments include educational approaches, psychological therapies which may include behavioral modification and/or medication. Ongoing assessment and treatment may be necessary.

About Shire

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.