FDA Approval of Sackler Clan’s Adhansia XR Raises Some Eyebrows

Certain family names gain notoriety. In the world of drug development (and the opioid crisis), the name Sackler is associated with billions-of-dollars in lawsuits, opioids, their company—Purdue Pharma—and to many, wanton greed. Recently, the clan created a subsidiary venture called Adlon Therapeutics L.P. Aside from other concerns about Adlon intentions (e.g. attempt to shield assets from potentially imminent bankruptcy)   the focus of this brief blurb is their newest approved drug.

Last month the Food and Drug Administration (FDA) approved their Adhansia XR methylphenidate hydrochloride-based, extended-release capsules. A central nervous system stimulant for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in patients six or older. In a stimulated Adult Workplace Environment (AWE) study, the drug exhibited statistically significant improvement over placebo at 1,2, 5,8,11 and 16 hours post-dose, but not at hour 14 post dose. The research was led by principal investigator Andrew J. Cutler, MD chief medical officer Meridien Research.  

The approval of this drug can be looked at from at least two vantages. On the one hand, it represents the ongoing, unswerving march for continuous refinement of various drug formulas for improved performance in a more guided, precise and targeted set of prospective patients. We believe that lead investigator Dr. Cutler is correct—there is a sub-segment of the ADHD population that could benefit from the key differentiating features of Adhansia XR—namely it’s 16 hour mechanism—the very reason why the FDA approved the drug last month. This is what separate Adhansia XR from its many methylphenidate-based rivals such as Ritalin, Concerta or Metadate, Daytrana, Quillivant, etc.

On the other hand, the Purdue or Sackler name raise eyebrows and more. Even this author’s gut flipped just a little when learning about the latest Sackler product to market. After all, there are billions in litigation right now and a raging opioid epidemic. There is a perception out there, and of course many lawsuits, that Purdue-based interests are driven by a propensity toward monetizing chemistry with highly addictive elements. Some key concerns expressed in the marketplace:

  • Methylphenidates can and are abused by drug addicts seeking an “upper” high similar to cocaine in some cases 
  • Most methylphenidate-based drugs are labeled against exceeding 60 mg per day (Adhansia XR is available in daily doses ranging from blue 25 mg to white 85 mg
  • Adhansia is the highest dose on the market and they seek to push it higher 
  • The dose lasts 16 hours which is not appropriate for most children
  • The manufacturer’s owners are engaged in approximately 2,000 lawsuits over OxyContin 

As therapeutic treatments become more targeted, precise and tailored for specific sub-segments of the population it is imperative that medical professionals and consumers educate themselves on the products offered in the market-when materially relevant to their life. Why did the FDA approve? What is the unique or differentiating elements? What are the risks? What is the personal cost/benefit analysis for one approach over another? As individuals do this they should share their learnings with others—when relevant and appropriate. In this way, we hope, the market will move in healthy directions.