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FDA releases fresh guidelines that compare new opioids with old ones before granting approval

Before stepping down from his position as the 23rd Commissioner of Food and Drug Administration (FDA) on April 5, 2019, Dr. Scott Gottlieb demanded for new approval standards to facilitate a comparison between proposed medicinal agents with the ones that were already available in the market.

In line with the above recommendations, the FDA recently issued a guideline to investigate the benefit-risk assessment of newly introduced opioid analgesics. The guideline, titled “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework,” puts forth some standards that will be considered by the FDA before it decides whether to approve a new opioid or not. The guideline runs through 7 pages and comprises 4 questions related to the efficacy and safety of drugs. According to the FDA, the drugs contesting for approval should have research backing the answers to these questions.

Questions related to efficacy and safety

The questions based on which the new drugs will be assessed are:

  • Is there any comparative data pertaining to its efficacy available corresponding to an already approved opioid and the new drug?
  • Is there any comparative data pertaining to safety available for the new dug to compare it with an already approved opioid or non-opioid painkiller drug? Does this new painkiller medicinal agent offer any additional safety benefits or shortcomings in comparison to the existing painkiller, for each and every indication, such as possibility of drug-drug interactions, potential for abuse, and so on?
  • How does the new drug fair in terms of the expected risk-benefit equilibrium when compared with the painkiller which is already approved, for each of the indications? Is there any availability of safety data which could be used for comparing the new drug with the approved non-opioid painkiller or an approved opioid? Moreover, does this new painkiller drug render additional advantages or disadvantages corresponding to safety when compared to the already existing approved painkiller drug for each indication, like lesser incidence of drug-drug interactions?
  • Are there any other advantages of this new drug over the other already existing approved painkillers, like can it be mixed with food?

Approvals will go beyond these questions

Despite the fact that responses to these four questions are extremely critical, the FDA also established in its guideline that this comparative data will be useful in assessing the benefits offered by the proposed drugs, however, it is not mandatory for a new drug to have superiority over an already available drug for getting an approval. The FDA also stated that the risk-benefit assessment of a new drug doesn’t end with its approval. It substantiated this claim by referring to a request that it made for the withdrawal of Endo Pharma’s reformulated Opana ER from the market because of the reported abuse in addition to the HIV epidemic from the sharing of needles amongst the opioid abusers in rural Indiana.

Ned Sharpless, acting FDA commissioner, issued a statement that stated that the FDA will continue to use evidence-based judgment when the benefits of a proposed drug stop outweighing the risks. He also noted that new authorities had been sanctioned which would be responsible for post-marketing studies to assess the efficacy of opioids and additional medicinal agents if it had reservations about these drugs not being as effective as perceived to be previously.

2014 draft guidelines withdrawn

While it released the new guideline, FDA also withdrew the 2014 guidelines pertaining to indications of painkillers. Sharpless stated the FDA strives to release many more guidelines in future so as to provide focused information associated with critical developmental areas.

Sharpless further added that the primary focus of the FDA will always be to combat the opioid crisis on every front. It will also assess how the presently available drugs are faring in the market in clinical and illicit settings and it will also take supervisory action whenever required.

Road to recovery

The ongoing opioid crisis in the U.S. is posing a huge burden and threat on public health and economic and social welfare. Paradoxically, the number of deaths due to opioid overdose continues to be on the rise. Unfortunately, opioid addiction, like any other kind of addiction, is difficult to overcome on its own. One needs professional support to deal with such addiction. 24/7 Recovery Helpline offers various addiction treatment programs to help people dealing with addiction embrace long lasting recovery.

If you or a loved one is battling an addiction and is looking for drug rehab help, get in touch with 24/7 Recovery Helpline. Call our 24-hour drug helpline 855-441-4405 and speak to a member of our team. We can connect you with rehab centers that offer multiple specialized programs customized to suit your treatment goals. These plans are designed by our multidisciplinary medical team keeping in mind the medical history of the patient. You can also chat online to a representative to get a free insurance verification today.

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