The implant was developed by Titan Pharmaceuticals and is licensed to Braeburn Pharmaceuticals for sale in North America, which is the largest market by far for drugs to treat opioid dependence.
Upward of 80 people fatally overdose on opioids each day in the United States.
Users of Probuphine will have its four small stick-like implants inserted in their upper arm during a doctor's visit lasting less than 15 minutes. The implant remains in the arm for six months before it is removed by a doctor.
Braeburn Pharmaceuticals reportedly has said it plans on pricing Probuphine competitively with other drugs that sell for around $1,000 and $1,500 per month, which is much more expensive than oral forms of buprenorphine.
"We have not announced specific pricing for Probuphine and will not do so until after the treatment is FDA approved," Braeburn CEO Behshad Sheldon said before Thursday's decision. "But, we can confirm that we will be priced lower than other long-acting medications currently on the market."
Sheldon also said that to ensure equal access to Probuphine for all patients, Braeburn will implement two initiatives.
One would be a exploring a rebate program for insurers, which "would mean that if the overall cost of care for a group of patients taking Probuphine exceeds the cost of treatment for the same patients in a prior six-month period, or a comparable group of patients taking other forms of buprenorphine (or other available opioid addiction medication) for a six-month period, Braeburn will give them a rebate for the difference," she said.
Braeburn also is establishing a payment assistance program for patients.
Sheldon told CNBC last month that there is already strong interest in Probuphine. About 4,000 doctors have asked to be trained in how to implant and remove the drug.
While 28,000 doctors are federally authorized to prescribe buprenorphine, only about 6,000 currently write about 90 percent of the total prescriptions in the U.S.
Research has shown that recovering addicts who do not manage their dependence with medication are significantly more likely to relapse into illicit drug use than people who take buprenorphine, which is often sold under the brand name Suboxone, or other medications including methadone and naltrexone. About a quarter of the 2.8 million people estimated to have diagnosed opioid abuse disorder take buprenorphine.
"Scientific evidence suggests that maintenance treatment with these medications in the context of behavioral treatment and recovery support are more effective in the treatment of opioid use disorder than short-term detoxification programs aimed at abstinence," said Dr. Nora Volkow, director of the National Institute on Drug Abuse at the National Institutes of Health.
Referring to Probuphine, Volkow said, "This product will expand the treatment alternatives available to people suffering from an opioid use disorder."
Sheldon of Braeburn said, "Opioid addiction is a chronic disease and should be treated the same way we treat other serious, chronic diseases — with evidence-based medicine."
"Probuphine is the first of what we hope will be many new and innovative approaches to treating this disease," Sheldon said.