Purdue Pharma’s ADHD drug faces doubts
STAMFORD — OxyContin maker Purdue Pharma has started to sell its first treatment for attention deficit hyperactivity disorder — a move that will test how its deeply controversial reputation will affect its push to diversify beyond pain drugs.
Facing more than 1,000 lawsuits that allege it has fueled the national opioid crisis with fraudulent OxyContin marketing, arguably no other drug maker has launched an ADHD medicine with as much outrage surrounding its older products. Now, with the launch of its Adhansia XR drug in a competitive and scrutinized market, Purdue will grapple with many doctors’ growing wariness of the pharmaceutical industry’s promotional tactics.
“If there is a new pharmaceutical out that seems superior, we will look closely at it and make sure it is appropriate to use or recommend,” said Dr. Anthony Rostain, a professor of pediatrics and psychiatry at the University of Pennsylvania’s Perelman School of Medicine. “We try not to let other factors interfere. However, in the case of Purdue, there’s been such a lot of concern. And with all the litigation, I do think it will affect prescribers’ willingness to use this product.”
In a statement, Purdue said that “while Adhansia XR is not appropriate for all patients with ADHD, we believe it has the potential to address an important treatment gap for certain patients who may require a longeracting medication.”
Large market
Produced by a new Purdue subsidiary called Adlon Therapeutics, Adhansia has joined a long line of prescription treatments for a widespread condition.
In 2016, about 6 million children in the U.S., between the ages of 2 and 17, had been diagnosed with ADHD at some point, according to the U.S. Centers for Disease Control and Prevention. The CDC cited data indicating that 5 percent of children have ADHD, although it said some studies have shown higher rates.
As diagnoses have grown, drug sales have burgeoned.
The global market for ADHD treatments was worth about $16 billion in 2018, and it is estimated to grow to nearly $25 billion by 2025, according to market research and consulting firm Grand View Research.
Adhansia is a drug for U.S. patients, with the company announcing in March it had secured the U.S. Food and Drug Administration’s approval. The medication comes in an extendedrelease capsule, and it is intended for patients 6 years and older.
The FDA’s backing was based on four clinical studies, involving 883 patients who were exposed to the drug during controlled treatments that ran between one and four weeks, according to Purdue.
In response to a Hearst Connecticut Media inquiry about whether the agency’s review of Adhansia took into account Purdue’s pending litigation, an FDA spokesman said “each application submitted must be reviewed and is judged on its own merits based on the
scientific data and information contained in the application.” He declined to comment further on that point.
Clouded by controversy
While it has secured the FDA’s endorsement, the fallout from the lawsuits still looms over the new drug.
The complaints from attorneys general — including Connecticut’s William Tong — assert that Purdue spread misinformation about OxyContin through deceptive advertisements, biased medical literature and relentless promotion by sales people who descended upon doctors’ offices across the country.
“The amount of damage they’ve done and the cost of the addiction crisis they’ve fueled is much bigger than the 3 percent of the marketplace that they constituted,” Tong said in an interview last month. “There’s no doubt that OxyContin played a lead role in fueling this crisis.”
Purdue and its owners, who are members of the Sackler family, have denied the lawsuits’ allegations.
The legal pressure, however, likely contributed to the company’s decision last year to stop its opioid marketing. It then disbanded its sales force. Those moves resulted in several hundred layoffs.
In response to a Hearst Connecticut Media inquiry, Purdue did not make clear if or how it would market Adhansia.
Dubious promoting of ADHD treatments has abounded for years. By 2013, the FDA had cited every major ADHD drug for false and misleading advertising in the previous 13 years, some for multiple infractions, according to a New York Times investigation that year.
“I tend to not pay a lot of attention to the marketing of any of the medications,” said Dr. Brian Keyes, a New Haven areabased child, adolescent and adult psychiatrist and member of the Connecticut State Medical Society. “I try to base it more on the science than the promotion… I don’t care what a brochure looks like. I want to know what the science is and how this (drug) will help or not help someone.”
The opioid crisis has reinforced many ADHD specialists’ circumspect attitudes.
“If there’s one good thing that came out of the opioid epidemic, it’s that most physicians are very jaded now about information that is provided by pharmaceutical companies,” said Dr. Carl Mueller, associate chairman of psychiatry in the Stamford Health system, which includes Stamford Hospital. “There’s been a shift toward much higher levels of skepticism. Ultimately, that’s a good thing.”
Assessing treatments
Adhansia is a “methylphenidate” medication, one of the two main stimulant groups for treating ADHD. Stimulants increase the brain chemicals dopamine and norepinephrine, which play crucial roles in thinking and attention.
Other methylphenidates, such as Novartis’ Ritalin, have been used for decades in ADHD regimens.
Amphetaminebased drugs, such as the Shiremade Adderall, comprise the other major type of stimulant prescribed for ADHD.
“There is no one, single best treatment,” Rostain said. “There are comparable treatments, and therefore we consider each of the compounds, either methylphenidate or amphetamine.”
Stimulants’ possible side effects include higher blood pressure and heart rates and increased anxiety — especially when they are taken excessively or otherwise misused, according to the National Institute of Mental Health.
Purdue said in its statement that its Adhansiarelated outreach to medical professionals would include several planned initiatives focused on preventing abuse and then monitoring for signs of misuse while patients were taking the drug.
Adhansia contains a boxed warning about the risk of abuse and dependence, while the company has recommended a starting daily dosage of one 25milligram tablet.
OxyContin’s packaging also contains a caution about its potential misuse, although the lawsuits still contend that the company misled prescribers and patients about the opioid’s risks. Purdue disputes those accusations.
“Our efforts will be focused on responsible and transparent interactions with the professional community to address needs in the existing population of appropriately diagnosed patients with ADHD,” the Purdue statement added. “These interactions will reiterate that (central nervous system) stimulants such as Adhansia XR, other methyl ph enid atecontaining products and amphetamines have a high potential for abuse and dependence.”
Growing pipeline
Purdue appears intent on developing more nonopioid medications — a strategy that is likely influenced by the steadily declining demand for OxyContin.
Growing skepticism among prescribers in response to the opioid crisis and increasing competition from generic drugs have significantly eroded its popularity.
OxyContin remains Purdue’s top seller, but its sales have declined in each of the past eight years, according to health care data and analytics firm Iqvia. Its 2018 sales of $1.4 billion compared with a tally of $3.1 billion in 2010.
Among other initiatives, earlier this year another new Purdue subsidiary secured the FDA’s “orphan drug designation” for expedited reviews of drugs to treat rare bileduct cancer and an extremely rare type of leukemia.
Around the same time, Purdue announced an FDA fasttrack designation for a “nalmefene hydrochloride” injection that would treat known or suspected opioid overdoses. The company said it would not profit from the that medication.
Purdue has not said if or how it would market those underdevelopment treatments.
“The aggressive marketing of any medication is now being seen with greater skepticism . ... People just want the facts,” Rostain said. “They just want to know what’s the role this might have and how might it be helpful. They don’t really appreciate the added hyping of the product.”