There have been a couple of news stories about buprenorphine over the last couple of days.
The first article looks at the business of pain medication, medications to treat side effects of pain medication and medications to treat addiction to pain medication.
Opioid prescriptions alone have skyrocketed from 112 million in 1992 to nearly 249 million in 2015, the latest year for which numbers are available, and America’s dependence on the drugs has reached crisis levels. Millions are addicted to or abusing prescription painkillers such as OxyContin, Vicodin and Percocet. Statistics from the Centers for Disease Control and Prevention show that, from 1999 to 2014, more than 165,000 people died in the United States from prescription-opioid overdoses, which have contributed to a startling increase in early mortality among whites, particularly women — a devastating toll that has hit hardest in small towns and rural areas.
The pharmaceutical industry’s response has been more drugs. The opioid market — now worth nearly $10 billion a year in sales in the United States — has expanded to include a growing universe of medications aimed at treating secondary effects rather than controlling pain.
There’s Suboxone, financed and promoted by the U.S. government as a safer alternative to methadone for those trying to break their dependence on opioids. There’s naloxone, the emergency injection and nasal spray carried by first responders to treat overdoses. And now there’s Relistor, the drug based on Moss’s work, and a competitor, Movantik, for constipation.
In colorful charts designed to entice investors, numerous pharmaceutical makers tout the “expansion opportunity” that exists in the “opioid use disorders population.”
Indivior, a specialty pharmaceutical company listed on the London Stock Exchange, sees “around 2.5m potential patients, the majority of whom are addicted to prescription painkillers,” as opposed to illicit drugs such as heroin. Another company, New Jersey-based Braeburn Pharmaceuticals, highlights “growth drivers” for the market, noting that millions of additional Americans not yet identified are also likely to be dependent on opioid painkillers.
Analysts estimate that each of these submarkets — addiction, overdose and side effects — is worth at least $1 billion a year in sales. These economics, experts say, work against efforts to end the epidemic.
If opioid addiction disappeared tomorrow, it would wipe billions of dollars from the drug companies’ bottom lines.
The second story is that 35 states (plus Washington DC) are suing Reckitt Benckiser for engaging in a variety of “deceptive and unconscionable” practices, including using “feared-based messaging” and “sham science” to keep generics out of the market by killing the tablet form of the drug so that they would be the sole purveyor of a patent protected version of the drug.
The plaintiffs in the lawsuit say Reckitt Benckiser took product hopping to a nefarious new level by using “feared-based messaging” and “sham science” to illegally subvert the market for Suboxone tablets while aggressively promoting its new film variation, which was introduced in 2010 and is under patent until 2023.
“The circumstances alleged in this case are particularly egregious in that, in the midst of an epidemic of opioid abuse and addiction… consumers and taxpayers have had to pay more for a drug that may help to mitigate some of the problem,” said George Jepsen, the attorney general of Connecticut, in a statement announcing the suit.
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Patent expiration is a conundrum faced by all drug makers and ordinarily it wouldn’t be a terribly big deal for a global monolith like Reckitt Benckiser—which generated more than $2.5 billion in revenue during the first half of 2016 through its ownership of popular brands like Lysol disinfectant, Mucinex cold medicine, and Durex condoms.
But nothing was quite like Suboxone, a blend of the painkiller buprenorphine and the opiate blocker naloxone.
. . .
By the time it lost its monopoly, Suboxone accounted for 85 percent of all spending on medication-assisted treatment in the U.S.—almost all of it subsidized by taxpayers—and Reckitt Benckiser was sitting on the pharmaceutical equivalent of a goldmine.
That’s when it got creative.
The plaintiffs accuse the company of undermining the market for generics through a “multi-step scheme” that began in 2010 with an aggressive effort to get prescribers to stop dispensing its own Suboxone tablets and replace them with the new film version.
Over the next two years, Reckitt Benckiser allegedly compensated doctors for being advocates of the drug, lobbied legislators on the benefits of Suboxone film, and penalized employees for not meeting sales targets for the new drug. It also raised the price of its tablets, making them more expensive than the newer film version, even though the pills are cheaper to make.
In September 2012, with generics getting closer to approval, Reckitt Benckiser announced its intention to take tablet versions of its drug off the market on the grounds that the pills posed a safety threat to children who might inadvertently eat them. On the same day it filed a “Citizen’s Petition” with the Food and Drug Administration calling on the agency to postpone approval of generics in the interest of public safety.
The company based its child-safety claims on a single study it had paid for itself.