FDA Approves Probuphine for Maintenance Treatment of Opioid Dependence

• Opioids are narcotic drugs used to relieve pain. They produce tolerance, addiction and physical dependence.
• Addiction refers to the constant craving for a drug and physical dependence is when the patient develops withdrawal symptoms after discontinuation of the drug.
• The USFDA has approved Probuphine, the first buprenorphine implant for opioid dependence, which provides long-acting treatment for a period of six months.
• Probuphine implant must be administered only by trained healthcare professionals who are certified under the Probuphine Risk Evaluation and Management Strategy (REMS) program

The U.S. Food and Drug Administration has approved Probuphine, a novel buprenorphine implant from the San Francisco-based Titan Pharmaceuticals Inc. and New Jersey-based Braeburn Pharmaceuticals to treat opioid dependence for six months. According to the Center for Diseases Control and Prevention (CDC), a more than 47,000 of the deaths recorded in the United States in 2014 were due to drug overdose out of which 61% were due to an overdose of opioid painkillers and heroin. Public Health officials are constantly trying to encourage innovative and better treatment options for opioid abuse.

Opioid Addiction and Dependence

Opioids are narcotic drugs derived from opium (poppy seeds) and are mainly used for pain relief. Drugs like morphine, heroin, and cocaine are well known for their psychoactive effects on the central nervous system. Side effects like sedation and respiratory depression are common with opioids and patients tend to develop tolerance or reduced effect, addiction and dependence over prolonged use.

Addiction, in general, refers to a chronic craving for a drug. It is a state of compulsiveness and strong desire to use the drug repeatedly by the individual to attain euphoria (state of well-being). On the other hand, physical dependence for opioids means that withdrawal symptoms appear on abrupt discontinuation of the drug. These effects can be minimized by the use of drugs like naltrexone, methadone, and buprenorphine which act on the specific opioid receptors and oppose the action of opioids.

Probuphine - An Innovative Implant

The Food and Drug Administration (FDA) has now approved the use of an innovative implant known as Probuphine, which is as small as the size of a match stick and has to be implanted into the arm to treat opioid dependence for a period of six months.

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FDA Commissioner Robert M. Califf feels that the approval for Probuphine will support the efforts of the patients to maintain treatment of opioid abuse and addiction as a part of their overall recovery program.

Buprenorphine, available in the form of tablets or films to be placed inside the mouth, is sold in the market to prevent withdrawal symptoms and reduce the craving for opioids. But these dosage forms have the disadvantages of either accidental drug overdose or stepping up of the dose by the patient. However, the novel implant drug delivery system of Probuphine emits or dispenses buprenorphine for a longer period of time and does not allow the patient to take extra doses.

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The approved Probuphine by FDA should be given to patients who are already stable on buprenorphine treatment. The FDA also states that the drug must be administered only by trained health care professionals who are certified under the Probuphine Risk Evaluation and Mitigation Strategy (REMS). About four implants of one-inch size each are inserted under the skin in the upper arm of the patient to provide long-acting treatment for about a period of six months.

Nora Volkow, MD of the National Institute of Drug Abuse at the National Institute of Health feels that Probuphine will increase the treatment options for opioid use disorder.

A clinical study on Probuphine demonstrated that the safety and efficacy of the drug in the treatment of patients with opioid dependence who were stable following treatment with buprenorphine. The study reported that about 63% patients who were treated with Probuphine did not use any illicit opioids during the six months. Probuphine has not yet been tested in those below 16 years or those above 65 years.

Demerits of Probuphine

Although Probuphine proves to be effective for the treatment of opioid dependence, it also poses some side effects such as nausea, vomiting, headache, toothache, back pain, constipation, depression and throat pain. It may also result in itching, redness and pain on the site where the implant is administered.

Caution: Probuphine must be dispensed and administered only by certified health care professionals who are trained under the Probuphine Risk Evaluation and Mitigation Strategy (REMS) as the surgical procedures for administration of implant under the skin may sometimes lead to risk migration or protrusion which would result in the expulsion of the drug, and nerve damage. There is also a risk of accidental overdose.

References:

1. FDA Approves First Buprenorphine Implant for Treatment of Opioid Dependence
   http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm503719.htm
2. Treating Addiction to Prescription Opioids
   https://www.drugabuse.gov/publications/research-reports/prescription-drugs/treating-prescription-drug-addiction/treating-addiction-to-prescription-opio
3. Increases in Drug and Opioid Overdose Deaths - United States, 2000 - 2014
   http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6450a3.htm
Source-Medindia