2023 Author: Bryan Walter | [email protected]. Last modified: 2023-05-21 22:24
For the first time, the US Food and Drug Administration (FDA) authorized a device, not a medication, to be named as a drug for reducing withdrawal symptoms. The FDA did so after reviewing data from a clinical study that found the device helped reduce symptoms of opioid withdrawal. Previously, the manufacturer had the right to officially declare it only as a means of reducing chronic pain, according to a statement on the FDA website.
After the termination of repeated and prolonged use of psychoactive substances, a person develops withdrawal symptoms. Its intensity and speed of formation, as well as the severity of specific symptoms, depends on various factors, including the type of substance taken. For the treatment of opioid dependence, various drug methods are offered, one of the most effective methods is methadone therapy, in which the patient takes methadone, which is also an opioid, but has several advantages. By gradually reducing the dose of its reception, the patient can achieve getting rid of addiction.
Innovative Health Solutions has developed a pacemaker behind the patient's ear called the NSS-2 Bridge. With a built-in battery and multiple electrodes attached to the ear, it can stimulate specific cranial nerves with electrical impulses. In 2014, the company received FDA approval for use as a chronic pain relief device.
Electrostimulator
The company conducted clinical trials of the device as a drug for reducing withdrawal symptoms from opioid withdrawal in 2016, the results of which were published in The American Journal of Drug and Alcohol Abuse in March 2017. According to a study in which 73 patients took part, after half an hour of using the device, the severity of withdrawal symptoms decreased by at least 31 percent.
The severity of withdrawal symptoms at different times after starting to use the device
It has now become known that the FDA has reviewed the data and has allowed the company to claim the device as a drug for reducing opioid withdrawal symptoms. It is only available with a doctor's prescription and costs between $ 600 and $ 800.
Recently, the US Food and Drug Administration approved another unusual medical device - a pill containing an electronic sensor that, upon contact with gastric juice, sends a signal to a smartphone through a special patch, and thereby allows the patient or the attending physician to track the frequency of admission. medicines.
