Explain a compounded formulation.
Naltrexone implantable pellets are a specially compounded, formulation of naltrexone that is patient specific (503A) only after a prescription is written by a medical caregiver who deems that the individual patient is a good candidate for the implantable formulation. Compounding is a common and legal process used by licensed pharmacies to create special formulations and/or combinations of FDA approved drugs based upon a doctor’s prescription. The pharmacies that make each implantable naltrexone pellet must strictly follow state and federal compounding laws. Naltrexone pellets have been used worldwide for over two decades. For more information about drug compounding, please visit the FDA’s website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding.
Is Naltrexone FDA approved?
Yes. Naltrexone was FDA approved in the pill form for the treatment of opiate addiction in 1984, and alcohol addiction in 1995. Naltrexone in implantable forms are not FDA approved, but have been used for over two decades via compounding pharmacies.
Why is the elimination of cravings important?
The freedom from the physical cravings for alcohol and drugs is critical. By removing the intrusive compulsion to drink or use, patients can refocus on their life, their relationships, their family, and the long-term psycho-social-behavioral aspect of the recovery. It is of particular importance during the first six months of recovery.
What is Naltrexone?
Naltrexone is a medicine that serves as an opioid receptor antagonist. It is used primarily in the treatment of alcohol and opioid dependence. Naltrexone blocks certain receptors in the part of the brain that triggers dopamine release and reinforces the compulsive addiction feedback loop. When these areas of the brain are blocked, the craving for alcohol and opiates is eliminated or significantly reduced. And if alcohol is consumed, the pleasure is very limited and the uncontrollable cascade of relapse is much less likely. If opiates are used, they will have no euphoric/pleasurable effect.
