Opioid Implant


JACKSONVILLE, Fla. (Ivanhoe Newswire) — 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. It’s called probuphine.

Forty-year-old Sarah Wilson is looking forward to moving her family into a nicer home.

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

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,” detailed Wilson.

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 buprenorphine implant called probuphine. It includes four rods, each about the size of a match stick, that are surgically implanted into the arm.

Jacksonville, Florida psychiatrist Amit Vijapura, M.D. said the implant, “Sits under the skin for six months and it gradually delivers the medicine every day, equal dosage.”

After six months, the rods are removed and the patient can decide if they no longer need treatment or if they want 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,” said Wilson.

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 because of it.

Contributors to this news report include: Cyndy McGrath, Supervising Producer; Jessica Sanchez, Field Producer; Milvionne Chery, Assistant Producer; Brent Sucher, Editor; Tony D’Astoli, Videographer.



TOPIC:            Opioid Implant
REPORT:        MB #4159

BACKGROUND: Probuphine 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, one-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.
(Source: http://www.rehabs.com/what-you-need-to-know-about-probuphine/ )

SAFETY: The safety and efficacy of Probuphine were demonstrated in a randomized clinical trial of adults who met the clinical criteria for opioid dependence and were considered stable after prior buprenorphine treatment.  Sixty-three percent of Probuphine treated patients had no evidence of illicit opioid use throughout the six months of treatment which was similar to the 64 percent of those who responded to sublingual (under the tongue) buprenorphine alone. Probuphine has a boxed warning that provides important safety information for health care professionals, including a warning that insertion and removal of Probuphine are associated with the risk of implant migration, protrusion and nerve damage resulting from the procedure.  The warning also recommends that patients be treated for pain with a non-opioid, whenever possible.  If opioids are necessary, doctors should monitor patients because higher doses may be needed to produce an analgesic effect.
(Source: http://www.titanpharm.com/pipeline/probuphine

Sherry Feldberg

If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Marjorie Bekaert Thomas at mthomas@ivanhoe.com

Doctor Q and A

Read the entire Doctor Q&A for Amit Vijapura,M.D.

Read the entire Q&A