In order to address the recent rise in opioid addiction in the United States, the Food and Drug Administration (FDA) has issued a draft guidance that would allow the industry to develop non-addictive drugs.
The draft submitted by the FDA is focused on making generic versions of approved opioids with abuse-deterrent formulations (ADF) a standard requirement in the drug manufacturing process.
Even though this is but one piece of a major plan to reduce the abuse of opioid medications, the FDA considers it a significant step towards stopping the abuse of generic versions of FDA approved opioids nationwide. Pharmaceutical companies have played a major role in the abuse of these medications, as they’re only a trip to the pharmacy away for any drug addict to purchase.
By introducing ADFs to its opioid medications, pharmaceutical companies would help reducing the high rates of drug abuse for this type of treatment because of the abuse-deterrent makes it harder for users to become addicted to the drug. In addition to this, the FDA also intends to generate a wider awareness of the dangers of opioid abuse in order to prevent users from abusing the medication.
For instance, by complying with the requirements for abuse-deterrent formulation in the manufacturing of an opioid medication, users would be significantly limited. Users wouldn’t be able to crush the pill and then snort it, or at least they wouldn’t find it as rewarding as it was without the ADFs.
Now, the inclusion of ADFs is being required for brand name drugs before getting approved by the FDA, according to the statement released by Modern Medicine Network. The FDA also declares that even though ADF won’t make the product impossible to abuse or the properties actually prevent addiction, this isn’t the only measure being taken in order to tackle the problem.
All in the same boat
The FDA is focused on solving the current public health crisis in the United States, yet it also acknowledges the part of patients who don’t abuse the opioid treatment. Consequently, the solution has to work for both the addicted users and the non-addicted, as they’re in the same boat.
Robert Califf, the FDA Commissioner said that generic opioids can provide patients suffering and in need of the medication an affordable treatment option. However, further studies are necessary for researchers to determine the best way to prevent users from abusing the opioid treatments, without harming the possibilities of suffering patients to ease their pain effectively.
In response to this challenging task, the FDA has required pharmaceutical companies with approved abuse-deterrent labeling products to help in this defiant situation. The FDA requires these companies to further analyze the effectiveness of the abuse reduction in practice by conducting long-term epidemiological studies.
This would provide scientists with sufficient data to accurately determine what causes users to get addicted to the opioid medications, and how can it prevented. Furthermore, the FDA will hold a press conference later this year where the draft guidance on generic ADF will be discussed. The range of issues related to the use of ADF technology to reduce the treatment abuse will also be discussed during the FDA meeting with the U.S. Department of Health and Human Services.
Source: Formulary Journal Modern Medicine