FDA Panel Recommends Approval Of New Opioid Addiction Treatment Tested By Jacksonville Doctor
A federal Food and Drug Administration advisory committee Wednesday recommended approval of a new injectable treatment for opioid addiction.
One Jacksonville addiction specialist participated in the drug trial that the panel examined data from.
The medication Buprenorphine has been around for years. It’s more well-known as the brand name tablets of Suboxone. It’s a chemical that blocks opioid receptors in the brain and it’s used to wean people off the more highly addictive painkillers.
The medical community has been split on how well that medication works in the long term. Some see its use as just replacing one addiction for another.
But Amit Vijapura, a Jacksonville doctor who specializes in addiction medicine, said this injectable type of buprenorphine significantly curtails the possibility of abuse.
“Having an injectable medication that physicians can control and know that patients are given the medicine and they don't have a chance to sell it on the street … it’s going to make a big difference,” he said.
For the last three years, Vijapura was one of a small group of Florida physicians participating in an FDA trial for the pharmaceutical company Indivior that treated around 500 opioid and heroin addicted patients that qualified. To qualify, patients had to be diagnosed with opioid or heroin dependency, understand the terms and conditions of the trial and had to be stabilized with buprenorphine tablets for at least a week.
The Jacksonville doctor said he treated and tracked 50 patients for six months, administering the injections — some at 300 mg, some at 100 mg and others placebos — and psychologically evaluating them.
Vijapura said with a single injection a month, an addict can get relief from both cravings and chronic pain.
“The medication is delivering buprenorphine every day at a consistent dosage for up to 30 days. It’s a very simple, one shot injection. It’s given subcutaneous[ly], so it’s under the skin, and it takes less than two minutes to give a shot and patient[s] can go on with their live[s],” he said.
Vijapura’s small, private practice was also part of an earlier trial examining the effectiveness of a buprenorphine implant that treats patients with dependency issues for six months at a time. That treatment was approved by the FDA last May, but Vijapura said the high cost of the outpatient procedure, and lack of insurer willingness to cover it, have made it unfeasible.
Some mental health and substance abuse groups, like the Citizens Commission on Human Rights International, are opposed to all versions of the drug, implants and injections included. That group likened the approval of these medications to “switching seats on the Titanic.”
Vijapura concedes buprenorphine alone is not enough to solve a person’s addiction. In his own practice, the practicing physician and psychiatrist advocates a combination of medication and traditional addiction therapy.
“When you combine medication-assisted treatment with rehabilitation program you get the best result,” he said.
The FDA is expected to make a final decision on whether the new drug should be widely available later this month.
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