As FDA encourages new medications for opioid addiction, roadblocks to treatment remain

The U.S. Food and Drug Administration is expected to issue new guidelines next month to encourage drug-makers to develop new and longer-acting medications for treating opioid addiction. But in Philadelphia, where an estimated 1,200 people died of overdoses last year, public health officials say their focus is on expanding access to medications that are already available.

The new FDA guidelines are part of its strategy for promoting drugs that can ease withdrawal symptoms and cravings for people addicted to opioids.

The guidelines would make it easier to get new medications approved that are shown to help in some way with a patient’s recovery, even if the person doesn’t stop using drugs completely.

“This is moving us in the right direction, but there are a slew of effective drugs that are already out there,” said Dr. Geoffrey Neimark, the chief medical officer for Community Behavioral Health, which runs Philadelphia’s network of addiction treatment providers for people on Medicaid.

Medication-assisted treatment, or MAT, is supported by evidence showing it to be more effective in keeping people off drugs than cognitive behavioral therapy alone.

Neimark said there’s still a lot of work to do to make the three medications the FDA has already approved more available to people seeking treatment. They include methadone, naltrexone (more commonly known by the brand name Vivitrol), and buprenorphine (known as the brand Suboxone).

“A lot of the work needs to continue to come on the policy front around ensuring and furthering access to what are already available drugs,” Neimark said.

There are a limited number of doctors and nurses who are authorized to prescribe Suboxone, which requires a special waiver from the federal government. Following the recommendations of Mayor Jim Kenney’s opioid task force, Philadelphia has been helping providers get the training certification they need to apply for the waiver.

According to data from the Department of Behavioral Health and Intellectual disAbility Services, the city’s public treatment system currently has capacity for about 2,200 more people to be receiving medication-assisted treatment. But it may not always be available when and where patients need it, Neimark said.

Integrating medication-assisted treatment into a variety of health care settings, such as emergency rooms and primary care offices, could help solve that problem, Neimark said.

Prior authorization requirements — where doctors have to get approval from an insurance company before being able to prescribe Suboxone — also act as a barrier for patients seeking to begin treatment, he said. While many commercial insurers have recently ended the practice, Pennsylvania’s Medicaid program still requires it. That can delay getting started on treatment and off opioids, Neimark said, and withdrawal symptoms can drive some patients to go back to using while they wait.