On Monday, August 6, 2018, the Food and Drug Administration announced that it plans on shifting the way it evaluates drugs to treat opioid addiction. Before, the FDA would examine a potential treatment medication only if the medication reduces opioid use. The FDA will now look at other factors when evaluating old and new medications for medication-assisted treatment; such as if the medication will reduce opioid overdoses and reduce the transmission of infectious diseases alongside reducing opioid use.
Why These Criteria for Evaluation of Medication Assisted Treatment?
The FDA pushing these new factors into the evaluation process is a huge step forward in opioid addiction treatment. There are many factors that contribute to successful treatment other than just reducing the amount of opioids being used. The FDA has seen the number of overdoses happening and wants to make access to opioid treatment medications easier to help prevent more overdose deaths. When someone is taking methadone, their body is still receiving opioids. It is enough to control cravings, and curb withdrawals. If they were to relapse back to illicit drugs, the risk of an overdose is significantly lower. Whereas someone who is completely abstinent returns to illicit drug use, they have no tolerance built to opioids anymore; they are extremely susceptible to an overdose. Overdose death prevention is one of the most important criteria being introduced by the FDA into the evaluation of medications for opioid use disorder.
Medication-Assisted Treatment Reduces Transmission of Infectious Diseases
Reducing the transmission of infectious diseases into the equation is a huge part of why medication-assisted treatment can help many people. Reported cases of Hepatitis C has nearly tripled over the past five years. Hepatitis C is an infectious blood-borne disease; it is only shared through contact with infected blood. With the increase of restrictions on access to hypodermic syringes, many users have shared needles at some point in their drug use. Hepatitis C can also be asymptomatic. Many do not know that they have contracted it and will spread it to other users unknowingly. By making access to opioid treatment medications easier, the FDA hopes that the risk of spreading infections will also go down since fewer people will be using or sharing syringes.
What Medications are Available for Opioid Use Disorders?
There are only 3 drugs on the market currently for opioid use disorder: buprenorphine (Subutex, Suboxone), methadone, and naltrexone. When any of these drugs are paired with psychosocial counseling, it is acknowledged to be the standard of care in treating opiate use disorder. Most recently, naltrexone has entered the market for opioid use disorder treatment. Naltrexone is either a once-daily pill or a once a month, long-acting shot.
One of the more significant issues most people face when seeking medication-assisted treatment, is that there isn’t enough funding to make it accessible to them. These medications are typically expensive, and many users or those just coming into treatment don’t have the means to pay for these medications. Legislation on Capitol Hill aims to ensure that more funding is obtained for methadone treatment. The new legislation would make medication-assisted treatment more available to those suffering from opioid use disorders. The new push by the FDA to make medication-assisted treatment more affordable is one of the latest efforts made in response to the opioid crisis.
The FDA is now encouraging pharmaceutical companies to consider outcomes beyond curbing drug use, such as lessening overdose deaths and the spread of infectious diseases when making new medications for opioid use disorder. With the FDA taking into consideration more than just stopping illicit drug use, medication-assisted treatment can help save lives. It can stop the spread of infectious disease like Hepatitis C and HIV. This is the beginning of making a stand against the opioid crisis.