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.
There is no discussion of the eventual price point of this drug. This is important if commonly used drugs like Adderall are becoming available as a generic and subsequently much less expensive. According to GoodRx.com, the cost for a 30-day supply of Adderall ranges from $75 to $150. Costs for Vyvanse, a newer stimulant for ADHD, costs around $250 for 30 pills. Concerta, which came on the market around the same time as Vyvanse, costs about $250 for 30 pills. Generic Ritalin (one of the oldest ADHD stimulant drugs) averages around $45 for a month’s supply.
Companies sometimes develop new, yet no more effective or safe, formulations because they can sell them at higher costs as a new patented drug.
The news release does a good job of explaining the benefits of the drug to children and adolescents with ADHD in relationship to a placebo and to a standardized measurement of improvement, but does not compare this new drug with existing treatments. It’s difficult to estimate how many people would want a stimulant that lasts 16 hours. Even if they do, it would be much cheaper to take a dose of an existing, shorter acting drug in the early afternoon.
The adverse effects are clearly listed and equated with those of other amphetamine drugs. The adverse effects that occurred in more than 5 percent of the subjects included decreased appetite, headache, insomnia, irritability, nausea, weight decrease and dizziness and were similar to those observed with other amphetamine compounds.
From the news release, the trial appears to be high quality. It is described as randomized, double-blind, multi-center, placebo-controlled, dose-optimized — all which would suggest the researchers followed high scientific standards. However, there is no accompanying peer-reviewed paper and the raw data and manipulated data are not available. The news release also does not tell us how many of the volunteers were on placebo and how many received the drugs.
This release does not take part in disease mongering.
It’s clear that the drug sponsor issued the news release and sponsored the study. We’re provided a quote from the study’s principal investigator (PI), Matthew Brams, an assistant professor at Baylor College of Medicine, but we’re not told what financial arrangements the PI had with Shire. According to ProPublica’s “Dollars for Docs” database, Brams (one of ProPublica’s designated top earners of speaking and consulting fees from drug companies) has received payments for serving as a consultant for Shire. That’s a disclosure we’d like to see in the news release.
While the news release mentions the existence of other drugs, this new drug is not compared to any of them but to placebo and a symptoms standardization tool.
The news release states the drug maker hopes to begin marketing the drug during the second half of 2017, after clearing FDA approval. We often look skeptically upon predictions of when a drug may be approved, especially when those predictions come from those with a vested interested, but this date seems far enough off that it won’t raise false hopes.
It is unclear from this news release if the drug is novel and if so in what way. It is an amphetamine drug and others like it are already in use.
There does not appear to be any unjustifiable claim being made here.