text_1: Shire Announces Positive Results of SHP465 Safety and Efficacy Study in Children and Adolescents with ADHD
text_2: This news release announces the results of a randomized, controlled Phase 3 clinical trial of a long-acting stimulant drug for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. The pharmaceutical company Shire completed this follow-up trial on the drug’s safety and efficacy after the Food and Drug Administration (FDA) required more data when Shire first sought approval for the drug. The drug was tested in children and adolescents aged 6-17 years old with ADHD. The company claims that the drug showed significant improvement in both children and adolescents when compared with a placebo and on the clinical global impression improvement scale, a standardized measurement of improvement. While the release is clearly targeted to investors and financial reporters, it was distributed and made available to a wide public audience. Just because a release is written for a business audience does not mean it should skimp on transparency. Its biggest weakness is the strong claims it makes without providing any links or references to published research where the results can be evaluated. We perused the company’s website for details of the study but came up empty-handed. The news release doesn’t mention the lead investigator’s financial relationship with the drug sponsor, projected costs of the new drug, nor make any comparisons with numerous similar drugs already on the market. This news release matters to the company since it is aiming to launch a new formulation (currently referred to as SHP465) of a drug similar to Adderall, also developed by Shire, which faces generic competitors. The new formulation essentially comes with a new patent for an old drug — the main difference being a longer half-life (or longer daytime effect) — 16 hours versus 12 hours for the current Adderall extended release pill. As the news release states, this new launch would extend Shire’s patent on its “ADHD Franchise” for many years: “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.” The news of a new drug formulation might be important for children and adolescents with ADHD who are frequently given amphetamines to treat their symptoms. But it is unclear how this drug differs from existing amphetamines already in use.