The U.S. Food and Drug Administration (FDA) issued a final guidance, “Opioid Use Disorder: Developing Buprenorphine Depot Products for Treatment,” which outlines the FDA’s current thinking about drug development and trial design issues relevant to the study of buprenorphine depot products, such as modified-release products for injection or implantation. The guidance includes minor changes to the draft document published in April 2018.
Improving access to prevention, treatment, and recovery services, including the full range of medication-assisted treatment (MAT), is a focus of the FDA’s ongoing work to reduce the scope of the opioid crisis and one part of HHS’ Five-Point Strategy to Combat the Opioid Crisis.
There are currently three FDA-approved drugs for MAT – methadone, buprenorphine, and naltrexone – that have been demonstrated to be safe and effective in combination with counseling and psychosocial support to treat opioid use disorder (OUD). Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse. At proper doses, buprenorphine also blocks the pleasurable effects of other opioids, making continued opioid abuse less attractive.
When combined with the right treatments and supports, novel formulations or delivery mechanisms described in the FDA guidance – including passive-compliance formulations such as sustained-release depots and implants – can provide effective treatment of OUD, and may result in less misuse, abuse, or accidental exposure compared to self-administered formulations such as transmucosal tablets and films.
The guidance outlines ways that companies can more efficiently advance innovations in buprenorphine depot products – from the data needed to support approval, to the specific review pathways that are available to help streamline how sponsors consider their development plans. It also details the types of studies the FDA recommends for buprenorphine depot products that are similar to an approved depot product, as well as buprenorphine depot products with novel features relative to approved depot products.
