A long journey to federal approval finally ended successfully on May 26 for makers of the first implant version of buprenorphine for the treatment of opioid dependence. The Food and Drug Administration (FDA) approved the six-month Probuphine implant, following the positive recommendation of its Psychopharmacologic Drugs Advisory Committee in January.
According to Kaiser Health News, the implant could cost about $1,000 per month, compared to oral buprenorphine at $130 to $190 per month.
Titan Pharmaceuticals and development partner Braeburn Pharmaceuticals had been denied in their New Drug Application for the subdermal implant in 2013, mainly over concerns at the time about the surgical insertion procedures for the drug. The administration of the drug, implanted at the inside of the upper arm, will require specific training in the surgical insertion and removal procedures, as there are risks of surgical complication (as well as accidental drug misuse if the implant ends up protruding from the skin).
The FDA news release announcing the approval states in part, “Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.” The agency goes on to state that counseling and psychosocial support should be part of any treatment for opioid dependence that includes the implant.
FDA is requiring that the manufacturers conduct postmarketing studies.
In this latest approval process, the implant's safety and efficacy were demonstrated in a trial of adult patients that found comparable percentages of opioid-free individuals during the six months of treatment with the implant and with sublingual buprenorphine (just under two-thirds of all patients in both cases). The implant is seen as improving patient convenience and compliance when compared with daily dosing of conventional buprenorphine tablets or film.