Share on Pinterest Purdue Pharma’s new ADHD medication is a higher dose of an older drug with a history of abuse. It’s been approved for children as young as six years old. Getty Images A new time-released formulation of a drug used to treat attention deficit hyperactivity disorder (ADHD) has been approved by the Food and Drug Administration (FDA) to treat children as young as six years old. It’s called Adhansia XR and its active ingredient is methylphenidate, which has been used to treat ADHD for more than 50 years. The same active ingredient has been the base for other brand-name drugs used to treat ADHD such as Ritalin, Concerta, Daytrana, Quillivant, Metadate, and Cotempla. So, what makes Adhansia XR different from most of the drugs that came before it? “The only difference in this new drug and the old ones is the higher dose,” Dr. Mary Ann Block, a Texas-based physician and non-pharmaceutical ADHD treatment author, told Healthline. Most methylphenidate-based drugs are labeled against exceeding more than 60 milligrams (mg) per day. Adhansia XR is available in daily doses ranging from blue 25-mg pills to white 85-mg ones. Adhansia XR also happens to be manufactured by Purdue Pharma, the company that made its fortune advertising, marketing, and selling oxycodone (OxyContin). The company is currently exploring bankruptcy in the wake of roughly 2,000 lawsuits that accuse the company of contributing to the opioid epidemic in the United States. Along with JORNAY PM (a similar new ADHD medication approved by the FDA), Purdue’s new medication is currently one of the highest dose ADHD drugs available on the market — and they want to go higher.

Same drug, new name Dr. Andrew J. Cutler has been researching ADHD for many years. The board-certified psychiatrist has been cited in dozens of studies in the pharmacological field and has been paid tens to hundreds of thousands of dollars a year by makers of those drugs. He now works as the chief medical officer for Meridien Research, which conducts “streamlined” medical research studies based out of Florida. One of his latest clients, he readily disclosed in an interview with Healthline, is Adlon Therapeutics LP, a new subsidiary of Purdue Pharma, the maker of Adhansia. Cutler says he was the clinical investigator in the Adhansia XR trials. According to Cutler, Adhansia XR falls into the “Ritalin family” of ADHD medications and that the research he helped conduct didn’t compare Adhansia XR with other drugs currently on the market. Instead, it focused on whether the drug started working within an hour and continued to work for 15 more in participants, all meeting the diagnostic criteria for ADHD. Some of the participants were new to the medications. Others were veterans of them. “Generally, they were satisfied,” Cutler said. On ClinicalTrials.gov, the government’s database of clinical trials, the drug isn’t listed as Adhansia XR, but as PRC-063. Purdue Pharma’s prescribing information packet includes how only 883 people were given Adhansia XR in three “controlled treatment periods” lasting one to four weeks. The studies used standard clinical trial procedures, such as being randomized, double-blind, placebo-controlled, crossover design, and even multi-center. One of those studies was published in October 2016 in the Journal of Attention Disorders, which concluded study participants had improved symptoms after one hour of taking the drug, continuing to about 16 hours, just as Cutler described. That’s why he said he’ll be “excited” when Adhansia XR is available later this year for his “age-appropriate adult clients.” The longer 16-hour dose from Adhansia XR, Cutler said, could also mean children don’t have to get a second dose of their medication from the school nurse. But even though it’s approved for children as young as six, Cutler said “a drug that lasts 16 hours may not be appropriate for children that young.” Dr. Max Wiznitzer is a pediatric neurologist and co-chair of the professional advisory board of Children and Adults with Attention-Deficit/Hyperactivity Disorder. He agreed that although approved for their use, the drug won’t be good for most children. “The vast majority of 6-year-olds don’t need 16 hours of medication,” Dr. Wiznitzer told Healthline. Instead, he assumes Purdue Pharma is chasing college kids and other adults — the only place of financial growth in the ADHD market. The drug’s soon-to-be available higher doses could find a niche in a certain subset of adults who need more medication merely because they’re several times bigger than a 6 year old. But, Wiznitzer said, there are other drugs out there, like Mydayis, that are already doing basically the same thing, and new on-patent ADHD drugs can run up to $400 a month. “It’s another variation on the scene. All it really is is another methylphenidate. The question is: What is the benefit?” he said. Experts agree that ADHD medications, when combined with behavioral therapy, should be started on the lowest possible dose. “Stimulant dosing is very individualized,” Cutler said. “There’s no one-size-fits-all.”