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New implant designed to treat opioid addiction

HOUSTON – Buprenorphine is fast becoming the treatment of choice when it comes to opioid addiction.

It used to only come in a pill or patch, but recently the FDA approved a first-of-its-kind implant that goes in the arm, called Probuphine.

It’s helping Sarah Wilson, 41, recover from her addiction.

“It’s like a fresh new start and I’m so excited,” Wilson said.

Wilson is now looking forward to moving her family into a nicer home. It’s something that wouldn’t have been possible just three years ago at the height of her opioid addiction.

“At the worst of it I was taking 30 to 35 Lortabs a day,” Wilson explained.

Wilson credits the opioid drug treatment buprenorphine as the salvation that turned her life around. She had been taking the oral form for three years before enrolling in the trial for the implant.

The implant has four rods, each about the size of a matchstick, that are surgically implanted into the arm.

Psychiatrist Amit Vijapura explains how the implants work.

“(It) sits under the skin for six months and it gradually delivers the medicine every day, equal dosage,” Dr. Vijapura said.

After six months, the rods are removed and the patient can decide if he or she no longer needs treatment or wants the rods implanted again on the other arm. This can continue for as long as the patient wants. Wilson immediately saw the benefits.

“You can travel and not have to worry about it getting lost in your luggage. You don’t have to worry about the pharmacy not having your medication ready,” Wilson added.

But there is a downside. If something happens and pain medication is needed, opioids won’t work with the implant. For Wilson, finding an alternative way to control pain is well worth it.

Dr. Vijapura said the other side effect of the implant, which is typical for any form of buprenorphine, is constipation. But he said it’s so mild he rarely has to stop the medication.

BACKGROUND ON PROBUPHINE

It is the first buprenorphine implant for the maintenance treatment of opioid dependence. 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. Until very recently, buprenorphine for the treatment of opioid dependence was only approved as a pill or a film placed under the tongue or on the inside of a person’s cheek until it dissolved. While it was shown to be effective, a pill or film may be lost, forgotten or stolen.

However, as an implant, Probuphine provides a new treatment option for people in recovery who may value the unique benefits of a six-month implant compared to other forms of buprenorphine, such as the possibility of improved patient convenience from not needing to take medication on a daily basis.
An independent FDA advisory committee supported the approval of Probuphine in a meeting held earlier this year. In addition, Probuphine should be used as part of a complete treatment program that includes counseling and psychosocial support. Probuphine consists of four 1-inch-long rods that are implanted under the skin on the inside of the upper arm, providing treatment for six months. Administering Probuphine requires specific training because it must be surgically inserted and removed.

Only a health care provider who has completed the training and become certified through a restricted program called the Probuphine Risk Evaluation and Mitigation Strategy (REMS) program should insert and remove the implants. If further treatment is needed, new implants may be inserted in the opposite arm for one additional course of treatment. The FDA is requiring post-marketing studies to establish the safety and feasibility of placing the Probuphine implants for additional courses of treatment.