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.
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.
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.”
The FDA says Adhansia XR has “no therapeutic equivalents,” meaning it’s one of a kind, mainly due to its 16-hour mechanism.
The FDA classifies methylphenidate as a Schedule II controlled substance. So while it has therapeutic value, it also has a high potential for abuse.
Adhansia XR comes with a boxed warning for “high potential for abuse and dependence,” the same as many drugs similar to it.
One deterrent of that abuse is its slow-release patented formula, but there are simple workarounds to get it straight into your bloodstream: crushing it to snort it or diluting it in water to inject it.
Newly approved higher doses of drugs with abuse potential are more attractive to experienced users, both legally and illicitly.
KemPharm, a company that specializes in making new versions of FDA-approved drugs so they can remain on patent, did an exploratory study on six adults who’d all used cocaine at least once in the last six months to find the ideal dose for recreational methylphenidate users.
It cited statistics that more than 8 percent of adults and nearly 17 percent of high school seniors reported using prescription stimulants for nonmedical use.
KemPharm conducted its study to test the abuse potential for a new extended-release methylphenidate-based ADHD drug it refers to as “KP415,” up to 240 mg.
Presenting their findings at the 65th Annual Meeting of the American Academy of Child and Adolescent Psychiatry last October in Seattle, Washington, they reported snorting 40 mg of methylphenidate provided the best balance of liking the drug’s good effects versus its unwanted effects, although 60 mg did receive the highest scores in every category.
But that’s not something drug manufacturers can legally put on a drug’s label, let alone advertise directly to consumers over the airwaves, online, or in print.
Other ADHD drugs like Ritalin weren’t advertised like that either. Neither was Purdue Pharma’s blockbuster opioid OxyContin.
In January, a lawsuit filed by the Massachusetts attorney general against the Sackler family, the founders of Purdue Pharma, produced emails that suggested they and other Purdue executives earned higher profits by pushing larger doses of the addictive pain medication oxycodone (OxyContin), all while knowingly ignoring warnings of the drug’s addictive nature and potential for misuse, according to an article in the the New York Times.
Stimulant medications such as Ritalin are powerful drugs that addiction research shows can rewrite a person’s basic brain function and should not be given out lightly.
A Purdue Pharma spokeswoman told Healthline the company has no plans to use direct-to-consumer advertising, rather focusing on “responsible and transparent interactions with the professional community to address needs in the existing population of appropriately-diagnosed patients. Ensuring the responsible prescribing and use of Adhansia XR is a priority.”
Dr. Adiaha Spinks-Franklin, a developmental behavioral pediatrician at Texas Children’s Hospital, said all stimulants have the potential of being abused, but research suggests that there’s less potential for abuse in longer-acting or extended forms because they take a few hours to start working and gradually wear off.
Short-acting drugs, she said, are more attractive for those misusing stimulants for their high.
“Long-acting stimulants are found to be more effective because of the slow onset, longer duration of action, and gradual decrease in blood levels,” Spinks-Franklin told Healthline.
For people like Jack J. Fernandes, chief executive officer of the newly formed clinical stage biopharmaceutical company Regenica Biosciences, that potential for abuse could be greater because those prescribing the same drug over many years could have unintended consequences.
One, Fernandes says, are the studies that show methylphenidate works on the brain like cocaine, starting with a surge of dopamine — creating a “high” — that causes some people to compulsively re-dose to regain that euphoric feeling.
“This can lead to a vicious cycle where the patient, through limited fault of their own, has a strong desire to take more, and the clinician, through old-school thinking, doesn’t suspect abuse when he or she writes the script for a stronger dosage,” Fernandes said.
Block, who treats children with ADHD without medication at The Block Center in Fort Worth, Texas, said she doesn’t see the need for a new drug using the same base ingredient.
“If a doctor wants to give a higher dose, an older drug can accommodate that,” she said. “The only reason to make another methylphenidate drug is to apply a new patent so that the cost to consumers of the drug can increase.”
Block said any formulation of methylphenidate is “highly addictive and much abused,” similar to cocaine. So much so that the two are used interchangeably in medical research.
“If a doctor suggested we give a 6-year-old cocaine to help them focus, no one would consider that,” she said. “But change the name to Ritalin, Concerta, or Metadate, and no one objects.”
While some experts question Adhansia XR’s approval after the fact, Purdue Pharma has posted a potential new clinical trial to test methylphenidate in dosages up to 100 mg a day.
A company spokesperson said current manufacturing capabilities limited Adhansia to pills up to 85 mg, but the 100-mg doses are expected to be available early next year.