Is Indivior’s New Drug a Game Changer For the Opioid Addiction Epidemic?

Indivior’s newly developed drug, Sublocade, may reshape the battle against opioid addiction.

Ear­li­er this month, the U.S. Food and Drug Admin­is­tra­tion approved Indivior’s exper­i­men­tal drug for pub­lic use in an attempt to fight America’s grow­ing opi­oid addic­tion issue. The Lon­don-based com­pa­ny, which spe­cial­izes in addic­tion treat­ment, cre­at­ed Sublo­cade, the first injectable drug for patients who are recov­er­ing from addic­tion to hero­in, pre­scrip­tion painkillers and oth­er opi­oids. With one injec­tion a month admin­is­tered by a health­care pro­fes­sion­al, the drug has the poten­tial to reduce abuse and relaps­es after patients stop tak­ing their cur­rent medication.

Accord­ing to an arti­cle by Newsweek, the drug was approved fol­low­ing two clin­i­cal stud­ies that includ­ed more than eight hun­dred adults who suf­fered from mod­er­ate-to-severe opi­oid use dis­or­der. The results revealed that those “who were inject­ed with Sublo­cade passed more urine tests and self-report­ed less drug opi­oid use dur­ing a six-month peri­od, com­pared to the place­bo group.”

This approval came at a good time as Amer­i­ca is expe­ri­enc­ing one of the dead­liest drug epi­demics in its his­to­ry. Accord­ing to ABC News, more than six­ty-four thou­sand Amer­i­cans died from drug over­dos­es last year, most of which involved opi­oids. How­ev­er, just how effec­tive will this drug be, and most impor­tant­ly, could it be the drug to help end the opi­oid cri­sis in America?

What are opioids?

Opi­oid med­ica­tions are clas­si­fied by the FDA as, “pow­er­ful pain-reduc­ing med­ica­tions that include pre­scrip­tion oxy­codone, hydrocodone and mor­phine, among oth­ers, and have both ben­e­fits as well as poten­tial­ly seri­ous risks.” They are main­ly giv­en to peo­ple to help soothe bod­i­ly pain after surgery or seri­ous injury. When tak­en prop­er­ly, these med­ica­tions can help man­age a patient’s pain, but when abused or mis­used, they can cause seri­ous harm.

Opi­oids impact opi­oid recep­tors in the spinal cord and brain to decrease the inten­si­ty of the pain peo­ple are feel­ing, accord­ing to the Nation­al Insti­tute on Drug Abuse. In addi­tion, it increas­es the amount of dopamine, which is a neu­ro­trans­mit­ter that caus­es eupho­ria, or intense plea­sure. Dopamine gets released into the lim­bic sys­tem that hous­es the brain’s reward cir­cuit, so our brain gets trained that the feel­ing we get from opi­oids is a good thing. This is why peo­ple can become so addict­ed to opi­oid med­ica­tion very quick­ly, even if they take the appro­pri­ate amount, their brain basi­cal­ly rewards them for tak­ing it.

Even though opi­oids are addic­tive, they are legal, so many doc­tors still pre­scribe them to patients who are in pain after an injury or surgery. Accord­ing to the U.S. Depart­ment of Jus­tice Drug Enforce­ment Admin­is­tra­tion, between 2006 and 2014, the most wide­ly pre­scribed opi­oid was Vicodin. In 2014 alone, 7.8 bil­lion Vicodin pills were dis­trib­uted in Amer­i­ca, quite an increase from the num­ber of 6.4 bil­lion dis­persed in 2016.

Doc­tors are start­ing to say no to opi­oids when try­ing to pre­scribe a pill for patients who have acute pain, which is pain that won’t last after a patient’s recov­ery from an injury or surgery. How­ev­er, the under­ly­ing issue at hand is the fact that there is a lim­it­ed sci­en­tif­ic direc­tion for doc­tors to fol­low while treat­ing chron­ic pain, which is pain that will nev­er go away, such as back pain and fibromyal­gia. Accord­ing to a study con­duct­ed by a Nation­al Insti­tute of Health expert pan­el, pre­scrip­tion of opi­oid med­ica­tion to treat chron­ic pain has increased dra­mat­i­cal­ly, but there’s lit­tle guid­ance on how to actu­al­ly use opioids.

Because there are no oth­er drug options to help peo­ple with chron­ic pain, doc­tors still pre­scribe patients pain med­ica­tion in hopes that it will at least make them feel more com­fort­able. This log­ic, cou­pled with the harm­ful effects of opi­oid med­ica­tion, have made many Amer­i­cans depen­dent on the drug to help soothe their pain, and once they have some of it, they need to keep tak­ing it, which has led to our cur­rent opi­oid crisis.

So, what is the opi­oid epidemic?

The opi­oid epi­dem­ic is not only the issue of addic­tion to opi­oid med­ica­tion, it’s also the issue of mis­use, abuse and sub­se­quent dead­ly over­dose cri­sis in Amer­i­ca. Every sin­gle day, more than nine­ty Amer­i­cans die after over­dos­ing on opi­oids and it is only get­ting worse.

The ori­gin of this cri­sis can be traced back more than twen­ty years to the 1990s when Pur­due Phar­ma, a big phar­ma­ceu­ti­cal com­pa­ny, intro­duced Oxy­Con­tin into the mar­ket. Oxy­Con­tin is a long-act­ing ver­sion of oxy­codone that slow­ly releas­es the drug over twelve hours. It was hailed as a major break­through in sci­ence because of its slow release and all-day com­fort to patients and gen­er­at­ed close to $35 bil­lion in rev­enue for the company.

The prob­lem? The harm­ful, sole ingre­di­ent oxy­codone, which is sim­i­lar to hero­in and up to twice as strong as mor­phine. That’s pret­ty pow­er­ful, which is why many doc­tors at the time were hes­i­tant to pre­scribe it. Pur­due Phar­ma found a way around those timid notions by fund­ing their own research so their doc­tors could claim that the drug was not addic­tive and com­plete­ly safe.

Oxy­Con­tin did help many patients with their intense pain, but many also became hooked on the drug, and by 1999, two hun­dred thou­sand Amer­i­cans died from Oxy­Con­tin over­dos­es and oth­er pre­scrip­tion opioids.

Fast for­ward to this past Octo­ber, Pres­i­dent Don­ald Trump declared the opi­oid epi­dem­ic a “nation­al pub­lic health emer­gency.” Trump went on to say that, “’Nobody has seen any­thing like what is going on now,” accord­ing to CNN.

Today, about a thou­sand peo­ple die every week from drug abus­es and two-thirds of those deaths are from opi­oid over­dos­es. It’s no won­der the opi­oid epi­dem­ic is now being regard­ed as the worst pub­lic health cri­sis in Amer­i­can his­to­ry, affect­ing peo­ple of all races, ages and eco­nom­ic stand­ing. The hard­est hit demo­graph­ic, how­ev­er, is white peo­ple and Native Amer­i­cans, which is a shift from pre­vi­ous drug epi­demics. Accord­ing to PBS, opi­oid deaths among white Amer­i­cans in 2014 was 7.9 deaths per one hun­dred thou­sand peo­ple, com­pared to 3.3 deaths per the same num­ber for black Amer­i­cans. The rate was even high­er amongst Native Amer­i­cans with 8.4 deaths.

Fur­ther­more, accord­ing to the same PBS arti­cle, peo­ple between the age of forty-five and fifty-four are more like­ly to die by opi­oids than any oth­er age group, with a whop­ping 11.7 deaths per one hun­dred thou­sand peo­ple. In com­par­i­son, mil­len­ni­als, peo­ple between the ages of fif­teen and twen­ty-four, had a rate of 3.1 deaths. These sta­tis­tics are scar­ing many civil­ians, gov­ern­ment offi­cials and med­ical professionals.

How Sublo­cade will affect the opi­oid cri­sis in America

Sublo­cade is the first injectable form of an old opi­oid addic­tion drug called buprenor­phine, com­mon­ly giv­en to recov­er­ing opi­oid addicts. Buprenor­phine pro­duces the same effects as opi­oids, such as eupho­ria, but start­ing at a low­er inten­si­ty and grad­u­al­ly increas­ing with each dose until they lev­el off. Due to this mech­a­nism, it low­ers the risk of mis­use, depen­den­cy and side effects.