On Thursday the Food and Drug Administration approved a once-a-month injection of the drug Sublocade for adults with opioid addictions who are already stabilized on medication.
The first injectable form of the leading medication used to treat patients addicted opioids has been approved by US health officials. This injection is meant to substitute the current daily medication and reduce the risk of dangerous relapses that happen when patients stop taking it.
The approval comes amid the deadliest drug epidemic in US history that killed 64,000 Americans last year – more than gun violence or car crashes. The FDA approved a monthly injection called Sublocade to treat those addicted to opioids.
There has been a longstanding gap in medication-based treatment for patients recovering from addiction to opioids, including the painkiller OxyContin and illegal narcotics, heroin and fentanyl.
THE ENORMITY OF AMERICA’S OPIOID CRISIS
Between 2000 and 2015, US deaths from synthetic opioids such as fentanyl, which is up to 100 times more powerful than morphine, rose by 1,125 percent. In the same 15 years deaths from all opioids rose by 294 percent.
Overall drug overdose deaths in the US reached around 64,000 last year – killing more people than gun violence or car crashes. This is up from 52,000 deaths in 2015, more than half of which were related to opioids.
And the new medication comes with a hefty price: $1,580 per monthly dose while older version of the drug, Suboxone, costs $100 a month. Drugmaker Indivior already sells the injection’s key ingredient, buprenorphine, in medicated strips that dissolve under the tongue.
The new injection is expected to cut down on abuse and diversion of buprenorphine, which is itself an opioid sometimes sold on the black market. Patients take the daily medication to control withdrawal symptoms including nausea, muscle aches and pain.
When dosed appropriately, the drug also reduces the euphoric effects of other opioids, discouraging abuse. But that benefit has not yet been shown in studies and the FDA is requiring Indivior to conduct follow-up studies on the drug.
Roughly 2.4million Americans are currently addicted to opioids and about 1.1million are receiving drug therapy to treat the condition. Suboxone is the most widely used drug, though access has long been limited by gaps in insurance coverage, caps on prescriptions and training requirements for would-be prescribers.
Last year the FDA approved an implantable pellet version of buprenorphine that releases the drug over six months. Other opioid abuse medications include methadone and naltrexone, an injection approved to treat opioid and alcohol addiction.
FDA Commissioner Scott Gottlieb has pledged to promote all available forms of medication-based addiction treatments. He has stressed that some patients may need to take the medications for life.
While studies show patients on medications like buprenorphine cut their risk of death by half, some recovery groups favor abstinence-only approaches to treatment. President Trump declared the opioid crisis a public health emergency in October.
On Thursday he pledged to donate his third quarter presidential salary of about $400,000 back to the government for programs to raise awareness of opioid addictions. Trump said the administration would beef up enforcement and treatment efforts, but that there was no substitute for prevention.