Naltrexone implants have not been evaluated for safety and effectiveness by the FDA and are not indicated or approved for treatment of any condition. However, there are several clinical studies on various naltrexone implants from around the world that can be found at the bottom of this page.
However, naltrexone is a medication approved by the Food and Drug Administration (FDA) that acts to inhibit cravings associated with the utilization of opioids and alcohol. Since its initial approval in 1984 as a tablet for use in the United States, medical professionals across the country and around the world prescribed it to help thousands of patients fight their addictions. For much of this time, naltrexone was mostly available by mouth and since at least 2006, by deep tissue injection into a person’s muscles. For safety and efficacy information and to learn more about the risks and benefits of naltrexone tablets and injectables, patients should review the prescribing information for such products and discuss with their physicians See, e.g., Revia PI; Vivitrol PI .
When, in the judgement of a treating physician, commercially available treatments are not adequate to address particular needs of his or her patient, subject to certain restrictions and requirements, the law permits the physician to direct a compounding pharmacy to make certain types of changes to such commercially available treatments (including dosage size or form) in a compounded product if in the physician’s judgment it will produce a significant difference for the patient. See, e.g. 21 USC § 353a (“Pharmacy Compounding”).
As the FDA notes:
Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the
supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. [C]ompounded drugs can serve an important medical need for certain patients, [but] they [can] also present a risk to patients. FDA’s compounding program aims to protect patients from unsafe, ineffective, and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.
FDA’s Human Drug Compounding Progress Report: Three Years After Enactment of the Drug Quality and Security Act (January 2017) For more information and resources respecting compounding and FDA’s view of its risks and benefits.
All forms of naltrexone first require that the patient first undergo detoxification for at least 7-10 days before commencing naltrexone treatment, in order to avoid a severe risk of precipitation of opioid withdrawal.
While the commercially available forms of naltrexone can be very effective when taken as prescribed, certain physicians have observed that the dosage form and duration of action of these therapies can present obstacles to compliance with subsequent dosing at critical early stages in the treatment process.. In the judgment of these physicians, the compounding and prescription of a long-acting naltrexone implant may present a way to leverage the attributes but overcome some of these obstacles posed by commercially available dosage forms.
After a brief procedure in which a small incision is made in the lower abdomen, to allow the implant pellet(s) to be inserted into the body and the incision site closed, the implant slowly releases naltrexone into the body over the course of time dependent upon individual patient factors and attributes of the compounded pellet(s).Within a short time after the procedure, the released naltrexone acts as it normally would to reach the receptors in the brain known to be associated with alcohol and opioid use effects. Blocking these receptors can help to reduce a person’s physical desires to continue using these substances, letting him or her focus on and therefore helping improve the effectiveness and maintenance of the addiction counseling and support components of the recovery process. As such, while by no means a cure for addiction, compounded naltrexone implants can play a vital role in helping people with alcohol and opioid addiction make a significant difference in their rehabilitation outcomes, even where they may have failed previously.
As noted above, the naltrexone implant has not yet been evaluated for safety and effectiveness by the FDA and is not indicated or approved for treatment of any condition.. It is produced under state and federal compounding guidance if prescribed and recommended by the patient’s physician. BioCorRx® does not diagnose, treat, or sell the program or naltrexone implants to patients BioCorRx Pharmaceuticals, a subsidiary of BioCorRx, Inc. is currently pursuing FDA approval of a specific naltrexone implant which is not utilized as part of BioCorRx® Recovery Program.
It can fairly be said that no drug is completely without risk, and that applies, even to the approved forms of naltrexone. Therefore, the determination as to whether lawfully compounded naltrexone implants or, for that matter, any commercially available anti-addiction medicine, may be appropriate to use in treatment of a particular patient, should be undertaken only in consultation with his or her treating physician after consideration of his or her particular conditions and circumstances.
Although not necessarily robust enough to meet FDA requirements, certain clinical studies have been performed with respect to naltrexone implants and addiction. Several links to literature respecting several of these are provided below for informational purposes only. Clearly, more information and research is needed. Accordingly, BioCorRx does not endorse or recommend these studies or the use of compounded naltrexone implants or for that matter, any particular anti-addiction medication to patients. Any decision as to which medication or treatment may be right for the patient must always be undertaken by the patient in consultation with his or her physician.
Using Naltrexone Implant in the management of the pregnant heroin user
Naltrexone moderates the relationship between cravings and meth
Naltrexone implants duration tolerability and clinical usefulness
Naltrexone Implants compared to methadone outcomes six months after prison release
Naltrexone Implant after in-patient treatment for opioid dependence randomized control trial
Naltrexone Implant for the treatment of polydrug dependence a randomized controlled trial
Naltrexone Implants for the treatment of amphetamine dependence a randomized placebo controlled trial
Mortality in heroin users 3 years after Naltrexone Implants or Methadone maintenance treatment
Genetic polymorph Naltrexone Implants
Favorable mortality profile of Naltrexone Implants for opiate addiction
Drug finding research analysis
Comparative treatment and mortality correlates and adverse event profile of Implant Naltrexone and sublingual buprenorphine
A systematic review and meta analysis of Naltrexone Implants for the treatment of opioid dependence
Retrospective assessment of the use of Naltrexone Implants for the treatment of problematic amphetamine use
*The BioCorRx® Recovery Program is a medically based program that’s only available from independent medical professionals, but it’s not a cure and doesn’t work for everyone. BioCorRx® does not sell to consumers and does not diagnose or treat individuals. Individual results will vary. Individuals should consult with their physician to determine if the program, or any portion of it, is right for them.