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)
- Opioids are narcotic
drugs used to relieve pain. They produce tolerance, addiction and physical
- Addiction refers to the
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
which 61% were due to an overdose of opioid painkillers
heroin. Public Health officials are constantly trying to encourage innovative
and better treatment options for opioid abuse.
‘Probuphine, the “first buprenorphine implant” is now approved by the U.S. Food and Drug Administration to provide long-acting treatment for opioid dependence.’
Opioid Addiction and Dependence
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
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
FDA Commissioner Robert M. Califf feels that the approval for Probuphine
will support the efforts of the patients to maintain treatment of opioid
and addiction as a part of their
overall recovery program.
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.
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
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
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.
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.
- FDA Approves First
Buprenorphine Implant for Treatment of Opioid
Addiction to Prescription Opioids
in Drug and Opioid Overdose Deaths - United States, 2000 - 2014Source: Medindia