FDA Commissioner Scott Gottlieb says making the drug in generic form will ensure that it reaches more people who need it. The drug is in the form of a thin film that is placed under a patient's tongue.
“The FDA is also taking new steps to address the unfortunate stigma that’s sometimes associated with the use of opioid replacement therapy as a means to successfully treat addiction," Gottlieb said. "Patients addicted to opioids who are eventually treated for that addiction, and successfully transition onto medicines like buprenorphine, aren’t swapping one addiction for another, as is sometimes unfortunately said. They’re able to regain control of their lives and end all of the destructive outcomes that come with being addicted to opioids."
Last month, the FDA approved the first non-opioid therapy for the management of opioid withdrawal symptoms. The drug Lucemyra treats symptoms common to withdrawal from opioids, including vomiting, muscle aches, and agitation.
The drug does not specifically counter addiction, but it can be part of a longer-term treatment plan by making it easier to stop using the addictive drugs. In approving the drug, the agency said the fear of experiencing withdrawal symptoms often prevents people with an opioid addiction from getting help.
Medicated-assisted treatment
The FDA says the approval of Lucemyra, along with this latest drug approval, is part of a strategy called medicated-assisted treatment (MAT), combining approved medications like methadone, buprenorphine, or naltrexone with counseling and other behavioral therapies.
The agency says regular MAT using buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, cancelling out the cycle of highs and lows often associated with opioid misuse or abuse.
Buprenorphine can also reduce the pleasurable effects of other opioids, making continued opioid abuse less attractive. The FDA cites Substance Abuse and Mental Health Services Administration data showing patients receiving MAT for treatment of their addiction are 50 percent less likely to suffer an early, preventable death.
The FDA said approval of generic versions of the drugs used in MAT therapies can lessen the cost and encourage the spread of MATs to counter the opioid crisis.