We need more options for drug addiction treatment and less expensive options. So the Food and Drug Administration should not be buying into large pharmaceutical companies’ claims that restrict the release of new treatments or drive up the price by awarding them sliding monopolies that continue long after the patent has expired.
While there is no cure for addiction per se, one of the most effective and undersold tools for opioid cessation is medication-assisted treatment (MAT): the use of certain FDA-approved drugs to stop someone from taking other drugs. There are two main types of MAT: opioid and non-opioid. Their use is still controversial, even among physicians. It is far easier to get a prescription for a drug that may cause addiction than a drug to treat addiction.
The most effective MAT drugs are methadone and buprenorphine (Suboxone), both of which are opioids, the same type of drugs they are used to treat. For this reason, they have a bad rep in the culture. Despite this, people with addictions who take methadone or buprenorphine are more likely to stay off OxyContin, heroin, and other addictive and damaging opioids, as well as functioning at their jobs, schools, home, and community. Taken as directed, they do not get the person with an opioid use disorder (OUD) high but will prevent the withdrawal symptoms and pain that send many back to their opioid use despite the desire to stay sober.
Some politicians, judges, and even physicians advocate only for non-opioids, saying that otherwise, you’re just trading one addiction for another. They say only non-opioids should be used for addiction MAT.
If no opioids are permitted, that only leaves naltrexone, often in the once-monthly injection Vivitrol, as the only MAT option. Naltrexone is an opioid antagonist: it actually blocks the effects of opioids even if you start using the opioids again.
The problem with naltrexone is that it means the person with OUD has to in effect quit cold turkey. If they are on the drug when the naltrexone is administered, they go into instant withdrawal. It does nothing to mitigate the craving for or withdrawal pains from opioids—though lofexidine (Lucemrya) was approved last year to reduce the cravings during a 14-day detox with naltrexone—and won’t stop you from getting high by using other non-opioid drugs, such as the stimulants cocaine and Adderall.
That Vivitrol needs to be administered only once a month is attractive. Methadone is most often administered daily—at a doctor’s office or methadone clinic—to prevent taking more than the daily prescribed dose. It’s true that in 2017 6.7 percent of all opioid overdose deaths were attributed to methadone, but that was far fewer than the deaths by heroin (32.5 percent), natural or semi-synthetic opioids (30 percent), and synthetic opioids other than methadone (59.8 percent).
Buprenorphine is six times safer than methadone and is now also available as a once-monthly injection (Sublocade) and a six-month implant (Probuphine). The problem with such new treatments is that they are expensive, especially at first, and insurance may not cover the cost. Competition can help lower the price, but not always. Even generic drug makers have been charged with price fixing and collusion to keep prices artificially high. And patent holders go to great lengths to hold onto monopolies by changing the drug slightly or creating a new delivery system, then claiming the old one shouldn’t be used any longer because it is not as good or even harmful.
Buprenorphine was originally told as a pill, Subutex. Then the company released Suboxone, an extended-release formula plus naloxone—an opioid receptor antagonist to block the effects of buprenorphine if crushed for misuse—and claimed Subutex was too easily abused. Suboxone sublingual film came next—harder to misuse!—and now Sublocade.
There is already a Sublocade competitor, Brixadi, ready to go next year, but Sublocade’s owners are claiming they should have another five years exclusive rights on the argument that it is an orphan drug. This is a misuse of the orphan drug designation (designed to encourage pharmaceutical companies to produce drugs for diseases that only afflict up to 200,000 people) for no other reason than greed.
MAT won’t cure addiction, but with the aid of other therapies—particularly cognitive behavioral therapy—it can lead to the cessation of substance abuse and recovery. More options and more affordable options make this outcome more likely.
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