Posts Tagged ‘probuphine update’

Probuphine Update


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.