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.
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.
The release cites Substance Abuse and Mental Health Services Administration (SAMHSA) data indicating that medication-assisted treatment for opioid use disorders reduces the risk of all-cause mortality by half. “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 National Institute on Drug Abuse (NIDA) director Nora Volkow, MD.
A second course of treatment with the implant will be allowed, and the FDA is requiring that the manufacturers conduct postmarketing studies to determine the feasibility of additional courses of treatment.
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.