The Future of Pain and Addiction Treatment: More Schedule III Options

I’m a family medicine doctor with a specialty in addiction medicine. I also have a certification in pain management. In my practice I regularly face a serious challenge: how best to treat patients with chronic pain while also helping them avoid or deal with addiction to prescription drugs.

I’ve helped award-winning actors and musicians, professional athletes, successful business executives, doctors, nurses, moms, dads, brothers and sisters — all struggling with the severe life-threatening disease of addiction. Chronic pain can be unbearable, and addiction to painkillers — as I’ve seen up close and personal — can make a bad situation much worse. Unfortunately, as we are learning, the opioid epidemic is spreading and raging like wildfire.

The most popular treatments for pain bring the risk of addiction along with needed relief. According to a recent article in the Wall Street Journal, generic Vicodin was the drug most widely prescribed to Medicare beneficiaries in 2013. Despite potential for misuse and abuse, powerful painkillers are widely used in contemporary medical care. An analysis of Medicare data found that more than half of the prescriptions came from family-practice or internal-medicine physicians. Researchers said the findings reflect the years-long increase in the use of opioid painkillers in the U.S.; approximately 691,000 providers prescribed Vicodin in 2013 to more than eight million Medicare beneficiaries, according to the Journal. According to the Centers for Disease Control and Prevention, nearly two million Americans either abused or were dependent on opioids in 2013.

One problem in treating chronic pain is the gap in viable treatments between over-the-counter pain relievers like acetaminophen (such as Tylenol) and ibuprofen (like Advil) and the very strong medications that are classified as Schedule II by the Drug Enforcement Administration (DEA). Most Schedule II medications are powerful opioids which, as the DEA makes clear, have a high potential for psychological or physical dependence and subsequent abuse. These medications include hydromorphone, methadone, meperidine, oxycodone, fentanyl, morphine, codeine and the most recent addition, hydrocodone, which in 2014 was transferred from Schedule III — a group of substances with less potential for abuse — to Schedule II. People experiencing chronic pain who use these substances — whether prescribed by their doctor or not — have a real risk of side effects, overdose and of becoming addicted.

A Middle Path: Buprenorphine

But just like Goldilocks — who rejected the beds that were too hard and too soft, finally falling asleep on one that was just right — a promising medication offers a middle path between milder over-the-counter and very strong Schedule II drugs. Buprenorphine is a Schedule III substance, but with a lower propensity for addiction and abuse compared to Schedule II drugs. It has been approved since 1982 as an injectable painkiller. And perhaps most important given the current opioid epidemic, since 2001, the drug has been allowed in its under-the-tongue form as a treatment for opiate dependence.

Buprenorphine has been referred to as the “unique” analgesic (painkiller) because it has a “ceiling effect” on respiratory depression, sedation and euphoria. This means that as doses of buprenorphine go up, the medication’s ability to cause an individual to stop breathing, pass out or “get high” plateaus. It should be noted that buprenorphine can be dangerous, especially in combination with other sedative hypnotics and to children, but that it is considered much safer than other opiates.

Buprenorphine was affected by the passage of the landmark Drug Addiction Treatment Act, passed by Congress in 2000. The act allowed physicians to become eligible to prescribe specially-approved opioid-based medications specifically for the treatment of opioid addiction. Buprenorphine is on the market in various forms: as an under-the-tongue generic tablet; as an under-the-tongue film (Suboxone); as a branded under-the-tongue pill (Zubsolv); and as a film that affixes to the inside of the cheek (Bunavail). Some may prefer the more efficient inside-the-cheek format since it doesn’t need to be kept in place under the tongue, making it more convenient for patients to talk, swallow and go about their normal daily activities.

Buprenorphine’s role in pain management in the U.S. has always been hampered by the lack of an approved, convenient and flexible dosage form. The injectable formulation is not practical and the long-acting patch formulation (Butrans) lasts one week at a time. This challenge is now being addressed by BioDelivery Sciences International, Inc. and Endo Pharmaceuticals, Inc., who recently announced that the Food and Drug Administration had accepted a new drug application for Belbuca (buprenorphine HCl) buccal film. [Full disclosure: I serve as an advisor for BioDelivery Sciences and have received an honoraria for speaking on their behalf.] A buprenorphine film that patients stick to the inside of their cheek, it is under development for “the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.” Belbuca involves the same inside-the-cheek administration as BioDelivery Sciences’ Bunavail (buprenorphine and naloxone buccal film) for the maintenance treatment of opioid dependence, but delivers buprenorphine alone rather than in combination with naloxone. Two late-stage clinical studies saw positive results, demonstrating safety and effectiveness in patients with chronic lower back pain. Study results were presented at the American Pain Society’s meeting.

Although all opiate-based products have risks for abuse and dependence, for those experiencing chronic pain, having access to more non-Schedule II options is a great thing. Buprenorphine products may offer promising alternatives to patients with less risk and great benefit.

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