The US Food and Drug Administration (FDA) on Thursday approved Braeburn Pharmaceutical's buprenorphine implant, Probuphine, to treat opioid dependence.
The implant works by providing patients with a low dose of buprenorphine for six months as part of medication assisted treatment (MAT) for opioid dependence.
In January, an FDA advisory committee narrowly backed the approval of the implant in a 12-5 vote. While supporters said Probuphine has advantages over pills because it is implantable, and thus harder to abuse, others have said the drug needs further study and have decried its high price tag compared to buprenorphine pills.
Probuphine is expected to be priced near $1,000 per month, just shy of the $1,100 per month price of Vivitrol, a once-monthly naltrexone injection also used to treat opioid dependence.
"We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives. Today's approval provides the first-ever implantable option to support patients' efforts to maintain treatment as part of their overall recovery program," said FDA Commissioner Robert Califf.
The agency also introduced new safety labeling changes for both buprenorphine and methadone to include information about the risk of neonatal opioid withdrawal syndrome (NOWS) when used to treat opioid dependence in pregnant women.
Drugs such as buprenorphine and methadone have been shown to be effective at managing opioid withdrawal symptoms when combined with counseling and behavioral therapy as part of a MAT program.
Before Thursday's approval, buprenorphine was only available as a pill or sublingual-film (dissolved under the tongue) that had to be taken daily.
According to FDA, clinical testing of Probuphine showed it was nearly as effective as buprenorphine in sublingual-film form, with 63% of patients having "no evidence of illicit opioid use throughout the six months of treatment," compared with 64% of patients taking the sublingual form.
FDA says the most common side effects of the implant are pain, itching and redness around the site of the implant, as well as other symptoms such as headache, depression, constipation and nausea.
Also, because Probuphine must be administered by a trained professional, and carries a risk of abuse if removed from the skin, FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS) for the drug.
Under the REMS, only health care providers who have gone through a certification course will be able to prescribe and administer the drug. The agency is also requiring postmarketing studies "to establish the safety and feasibility of placing the Probuphine implants for additional courses of treatment."
FDA – Probuphine