Probuphine: Formidable Hurdles Will Severely Limit Adoption

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Addiction Expert Dr. Indra Cidambi Spells Out Why New FDA Approved Opioid Addiction Implantable Drug, Probuphine, Will Flop

The Food & Drug Administration (FDA) announced today its approval of Probuphine, an implantable form of buprenorphine, a medication used to treat opiate addiction. It works by reducing cravings and withdrawal symptoms.

“Probuphine could positively impact medication compliance and help individuals seeking longer-term treatment for Opiate Use Disorder,” says Dr. Indra Cidambi, leading Addiction Expert and Medical Director at Center for Network Therapy, New Jersey’s first licensed outpatient detox facility. “However, implementation challenges will severely limit the adoption of Probuphine.”

Of the roughly 2.5 million Americans addicted to opiates, it is estimated about 20% are addicted to illegal opioids, such as heroin, and the other 80% are addicted to prescription opioids, such as oxycodone, hydrocodone, methadone, hydromorphone and codeine. Less than half of these individuals receive medication-assisted treatment to address their substance use disorder, suggesting a vast market.

“Probuphine offers important benefits not currently provided by other forms of buprenorphine. For example, since Probuphine is in implantable form, the medication is gradually released into the blood stream, helping medication compliance,” says Dr. Cidambi. “But, the processes related to dispensation of the medication make it impractical.”

Dr. Cidambi shares six reasons why she believes Probuphine will flop:

1.    Efficacy Not A Given: “Probuphine is recommended for people requiring 8mg of buprenorphine or less a day. If this dosage proves to be less than one needs, it’s possible that an individual in recovery may seek opiates on the streets in order to satisfy cravings or avoid withdrawal,” said Dr. Cidambi. “Also, Probuphine will ‘incentivize’ patients not to attend counseling in conjunction with medication assisted treatment, as they have to see their doctor only once every six months. This may inhibit their recovery as they ignore the lifestyle changes they need to make and rely solely on medication,” says Dr. Cidambi.

2.    Co-Abuse of “Benzos” Could Prove Dangerous: If individuals implanted by Probuphine co-abuse other class of drugs, such as benzodiazepines, the effect is the same as using opiates and benzodizapines together – i.e. increased risk of respiratory depression. As per NCBI, co-abuse of benzodiazepines and opiates increased by 570% from 2000 to 2010. So, if these individuals do not participate in counseling they are unlikely to be monitored for abuse of other substances and this could prove dangerous.

3.    Prescribers Lack Surgical Skills: “Probuphine requires a physician with some level of surgical skill to implant the medication under the skin,” says Dr. Cidambi. Currently family/general practitioners, Doctors of Osteopathy, internists and psychiatrists write nearly three-fourths of buprenorphine prescriptions, and only a small percent of prescriptions is prescribed by doctors with training in surgery. “While Probuphine’s manufacturer expects doctors prescribing buprenorphine to undergo training to learn to implant Probuphine, it is hard to envision this happening - a physician’s office may not be set up to perform a surgical procedure; a physician may not want to deal with complications resulting from such procedures; and participating physician’s malpractice insurance rates may be negatively impacted due to inclusion of surgical procedures,” added Dr. Cidambi.

4.    Divided Care Cumbersome: “If enough current prescribers of Buprenorphine do not participate in the Probuphine implant program (even if they participate in the prescriber program), it would lead to divided care,” says Dr. Cidambi. “In that scenario, the prescriber (likely an addiction specialist) would have to be present when the surgeon (or equivalent) performs the procedure, which would create logistical headaches. Also, who is responsible for the patient? The doctor who prescribes the medication or the doctor who implants it? And who provides follow-up care?” asks Dr. Cidambi.

5.    Implant Removal Difficult: A study showed that only seven out of 15 specialists who participated in the trial were able to remove all four implants successfully and the other eight followed ‘proper procedure.’ “What this means is that the eight did what was recommended when they could not take the implant out. The problem seemed to be that the implant was not palpable (the physician could not feel the implant through the skin). So, they would have to send the patient for imaging in order to locate the implant. This, obviously becomes unwieldy,” says Dr. Cidambi.

6.    Unpalatable Accounting Requirement: Probuphine is to be distributed under a ‘closed distribution system,’ which means that the manufacturer will ship the product directly to buprenorphine providers trained to implant the drug. “The providers would have to store the medication (a controlled substance) in their offices and then implement an inventory and accounting system for the controlled substance. The responsibility of storing the medication and additional paperwork will be a strong deterrent to providing the implant,” observes Dr. Cidambi.

For more information on substance abuse dependency, addiction and treatment, please go to http://www.recoveryCNT.com.

About Dr. Indra Cidambi
Indra Cidambi, M.D., Medical Director, Center for Network Therapy, is recognized as a leading expert and pioneer in the field of Addiction Medicine. Under her leadership the Center for Network Therapy started New Jersey’s first state licensed Ambulatory (Outpatient) Detoxification program for all substances nearly three years ago. Dr. Cidambi is Board Certified in General Psychiatry and double Board Certified in Addiction Medicine (ABAM, ABPN). She is fluent in five languages, including Russian.

About Center for Network Therapy
Center for Network Therapy (CNT) was the first facility in New Jersey to be licensed to provide Ambulatory (Outpatient) Detoxification Services for all substances of abuse – alcohol, anesthetics, benzodiazepines, opiates and other substances of abuse. Led by a Board Certified Addiction Psychiatrist, Indra Cidambi, M.D., experienced physicians and nurses closely monitor each patient’s progress. With CNT’s superior client care and high quality treatment, Dr. Cidambi and her clinical team have successfully detoxed over 600 patients in nearly three years.

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Marisa Amador
Rubenstein PR
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