The Food and Drug Administration (FDA) this week asked for more information on an implant designed to treat opioid addiction, before making a decision on whether to approve the drug, according to Bloomberg News.
Probuphine is a long-acting version of the opioid dependence medication buprenorphine. It is implanted under the skin of the upper arm, in a procedure that takes about 10 to 15 minutes in a doctor’s office. It remains in place for about six months. The FDA asked for more information on the effect of higher doses of Probuphine, and on how doctors would be trained to insert and remove the implant.
In March, an advisory panel to the FDA recommended the agency approve Probuphine, made by Titan Pharmaceuticals, but voiced concerns about the safety of the manufacturer’s marketing plan.
Members of the panel said they were concerned about the safety of the company’s marketing plan, because of the potential for abuse of the drug. They also said they were not convinced the intended dose of Probuphine would be effective enough.
Doctors must be trained to implant the drug, and some of the FDA advisors said they were concerned Titan had not adequately planned for the training.
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