New FDA guidance on development of sustained-release buprenorphine for treatment of opioid dependence

The first of two pieces of draft guidance concerning treatment for opiod dependence has been released by the US Food and Drug Administration.

Office of the US Food and Drug Administration

The US Food and Drug Administration (FDA) has published the first of two new draft guidance documents aimed at helping the pharmaceutical industry develop drugs for use in medication-assisted treatment (MAT) for opioid dependence. 

The first piece of draft guidance, ‘Opioid dependence: developing depot buprenorphine products for treatment’ focuses on the ways drug companies can more efficiently explore innovations in sustained-release ‘depot’ buprenorphine products.

According to the FDA, passive-compliance formulations (those that do not require taking a daily medication), such as sustained-release depots or implantable devices that release a continuous level of the drug, can provide effective treatment of opioid dependence. It adds that these formulations may also result in less misuse, abuse or accidental exposure, compared to self-administered formulations, such as tablets and films, which are absorbed through mucous membranes in the mouth.

The FDA says that regular adherence to MAT with buprenorphine helps patients gain control over their use of opioids without causing the cycle of highs and lows, and intoxication and withdrawal associated with opioid misuse or abuse.

“Today’s action by FDA reflects the Trump administration’s commitment to bringing the best science we have to bear in the fight against opioid addiction, said US Department of Health and Human Services secretary Alex Azar.

“FDA Commissioner Scott Gottlieb has made advancing medication-assisted treatment a priority at FDA in particular, and we believe this new guidance can help accelerate the pathway for developing new drugs and new formulations of existing drugs.”

The FDA intends to issue more guidance that will provide a framework for the development of novel clinical endpoints that can form the basis of additional MAT product approvals.

Last updated
The Pharmaceutical Journal, New FDA guidance on development of sustained-release buprenorphine for treatment of opioid dependence;Online:DOI:10.1211/PJ.2018.20204718

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