RICHMOND, Va. – In November, the FDA approved Sublocade, a first of its kind treatment developed by a Richmond-based pharmaceutical company Indivior for moderate to severe opioid disorder.
“It’s a sustained release buprenorphine injection that releases plasma concentrations of the medication buprenorphine into the system over at least 30 days,” said Sublocade clinical investigator Dr. Brent Boyett.
In an opioid study, Sublocade achieved a complete blockade of drug-liking effects for a full month in most patients.
Shaun Thaxter, Chief Executive Officer of Indivior, explained that Sublocade is intended to help patients obtain a more weeks free of opiods.
Sublocade is injected into the abdomen and it is for patients that have been on buprenorphine treatment for a minimum of seven days.
“It’s known as medical assisted treatment so medications assist with other therapies like cognitive behavioral therapy, motivational enhancement, group and 12 step facilitation those kind of therapies that work along with the medication in order to help the patient get better,” said Dr. Boyett.
Until now, it’s only been available as a tablet or film that dissolves in the mouth, or as an implant.
“Once you receive this injection it’s a commitment for at least 30 days,” said Dr. Boyett. “Without medication opioid use disorder, even with the best cognitive therapies, motivational enhancement and counseling, without medications, those therapies are only about 10% effective even less in many cases.”
Dr. Boyett says it controls physical withdrawal and cravings after opioids are discontinued and can only be administered by a healthcare provider.
“We know buprenorphine is traded on the streets and commonly misused. The fact that this medication will be administered in a physician’s office should mitigate that significantly, said Dr. Boyett. “This mitigates diversion, assures compliance and thirdly the case of pediatric poisoning.”
The FDA gave Sublocade fast track approval.
“I think it’s a really big deal,” said Dr. Boyett. “It illustrates the urgency the FDA feels about creating good treatment options for opioid use disorder,” he added. “We’re in the midst of an epidemic there were over 60,000 overdose deaths from opioids in 2016 so it’s an all hands on deck approach. The FDA recognizes the urgency to get to market therapies that help.”
FDA Commissioner Dr. Scott Gottlieb said that the FDA is committed to expanding access to treatments that can help people pursue lives of sobriety.
“As part of our ongoing work in supporting the treatment of those suffering from addiction to opioids, the FDA plans to issue guidance to expedite the development of new addiction treatment options,” Gottlieb said in a press released, in support of Sublocade. “We’ll continue to pursue efforts to promote more widespread use of existing, safe and effective FDA-approved therapies to treat addiction.”
Maggie Garrett is one of several addicts recovering at Richmond’s McShin Foundation who said they would be willing to try Sublocade. Garrett wants to do what it takes to stay sober for her unborn child due in July.
“If it was my life or death yes, and for my children so I stay sober, so I can be responsible and productive member of society absolutely,” said Garrett.
“It would keep me safer from going back out and using,” she added. “I don’t want to end up back in jail and not be there for my child. I don’t want to lose my child to social services. I don’t want to be that kind of mother. I don’t want to go wrong this time.”
But other recovering addicts say they want a life free of dependency and that buprenorphine treatment hasn’t worked for them in the past.
“It has never stopped me from wanting to use heroin, never not once,” said Leann Wood.
“It sounds great but it doesn’t work for me,” said Joseph Lecato. “It’s either all or nothing with drugs for me.”
“It is a controlled addiction,” said Dr. Boyett. “There are certain reasons why this is a much safer way to control the disease than the drugs that the patients are using on the streets.”
Doctors recognize this is not for everyone and that it’s not a cure.
“This medication will no more cure the disease of addiction than insulin cures diabetes,” said Dr. Boyett.
But Boyett says it provides another tool for physicians to help save more lives.
“It’s saved countless lives. This has the potential to be a game changer in the field of opioid use disorder management,” said Dr. Boyett. “This therapy, along with counseling and services that go along with it can dramatically and rapidly turn a person around within a matter of one to two weeks we see a change.”
Sublocade comes in 100 and 300 milligram doses and will be available as early as next month.
The doses can run $1,580 per month, but manufacturer Indivior said a co-pay assistance program will be available, that could reduce that to as little as five dollars a month for qualifying patients.
The company says since this is a restricted program and not on the market yet it does not yet have a list of participating doctors.