Posts Tagged ‘buprenorphine implant’

Probuphine Implants: Impractical?

Probuphine

The more I learn about Probuphine, the less I think it will be practical for use in the average office-based opioid use disorder treatment setting. I predict it will be a specialty medication implanted by a few practitioners who take referrals from other doctors.

Braeburn Pharmaceuticals is sponsoring conferences for doctors to learn how to insert Probuphine, the form of buprenorphine that’s implanted under the skin like Norplant, the birth control medication. This medication is marketed by Titan Pharmaceuticals. Probuphine consists of four slender rods that are inserted just under the skin at the upper arm. These rods release buprenorphine over six months, when they have to be removed, and new rods implanted.

I wasn’t sure I wanted to do Probuphine implants, but I liked the idea of being able to do it, so I asked to attend one of their conferences to learn the procedure.

Alas, the company says only doctors who have performed minor surgical procedures over the past ninety days are eligible to learn to be an implanter of Probuphine. I can still prescribe it if I take the course, their letter says, but I’d have to refer to someone else to implant Probuphine.

Huh? I thought I could prescribe it already, since I have an “X” number. Maybe not.

If I can prescribe it but I can’t administer it, why would the patient see me at all? Why not just go directly to the doctor who can prescribe and implant?

I looked around the room during my recent addiction medicine conference and tried to imagine how many of these specialists had done surgical procedures over the past three months. There was one surgeon, and a few obstetricians, so I decided three out of sixty or so of the doctors who presently prescribe buprenorphine.

Even if the FDA approves Probuphine in May, I have a hard time imagining how Probuphine could be used in a typical office-based buprenorphine practice.

Because besides the implantation conundrum, who pays for it? Drug company representatives were unable to answer questions about the cost.

And how does the implant, the implanting physician, and the patient all arrive at the appointment time? Is the doctor expected to order the implant, store it in her office, and hope the patient shows up for the implantation? Surely we couldn’t give a prescription to the patient to take to a pharmacy for the implant, so I’m not sure how that’s going to work.

Won’t this medication need prior approval? Representatives from the drug’s manufacturer say “no,” but I have a hard time believing that.

I picture one or two sites in North Carolina that will have the resources to do the implants and probably keep them in stock, perhaps at a hospital pharmacy. Maybe the teaching hospitals will have the resources to do this.

Also, the Probuphine delivers drug levels equivalent to six to eight milligrams of sublingual buprenorphine, so patients at higher probably won’t be considered.

I’m starting to doubt the practicality of Probuphine at an average addiction medicine physician’s office.

Probuphine Update

probuphine

Sorry it’s been some time since my last post; I broke my leg, had to have surgery, and only recently got out of the hospital. How’d I break my leg, you ask? Ah, I had a little trouble sticking the landing of that double axel…ok that’s not true…I broke it walking the dog.

And here is an update regarding the latest on Probuphine…

Probuphine, a new implantable form of buprenorphine, was not approved by the FDA, despite a recent recommendation by the FDA’s advisory committee to approve this new form of buprenorphine. This drug is better known under the brand name of the sublingual form, Suboxone.

According to last week’s Alcoholism and Drug Abuse Weekly, Titan Pharmaceuticals, maker of Probuphine, was told by the FDA they needed more information to show that Probuphine provided adequate opioid blockade , and they needed to show the effects of a higher dose of Probuphine. According to studies, the present formulation of Probuphine gave a lower buprenorphine blood level than compared to the sublingual form dosed at 16mg per day. The FDA asked for testing of the training that’s planned to be given to physicians who implant and remove the Probuphine cylinders.

I was quoted in the article; as I stated in an earlier blog entry, I think the present formulation of Probuphine under-dosed patients in Titan’s study. I think it should be re-formulated so that more medication is released per cylinder. Patients switching from sublingual could have their Probuphine dose varied according to how many cylinders are implanted. I also criticized the complicated procedure for both implantation and explantation. Doctors with Suboxone waivers can store the cylinders in their offices, but we’d have to assure security of the substance and keep records for the DEA. We would also have to be present with the surgeon during implantation and explantation, which is not financially practical for me, at least. Some Suboxone doctors may decide they want to learn to do the implants themselves.

I see a possible area for use of Probuphine in incarcerated opioid addicts. Prison systems say they don’t want to try to dose inmates with a controlled substance, because of diversion fears. With Probuphine, there’s less risk of diversion, and inmates’ opioid addictions could be treated with Probuphine implantation every six months. This may not give ideal blood levels, but it’s far better than letting a person with opioid addiction endure opioid withdrawal while incarcerated, which does nothing to help the underlying disorder. These people would still need psychosocial addiction treatment, though.