Is the Key to Pain in a Schedule 3?

By Matthew A. Torrington, M.D.

How should pain specialists approach the challenge of initiating treatment for chronic pain? While many beneficial options exist, some doctors today may perceive a gap between over-the-counter medicines and the Schedule 2 prescription substances, which carry with them significant restrictions for prescribers, pharmacies and patients. This is due in part to the U.S. Drug Enforcement Agency’s decision to transfer all hydrocodone combination products (HCPs)—including commonly known drugs such as Vicodin or Norco—from the less-restrictive Schedule 3 classification to the more restrictive Schedule 2 in August 2014.

In light of the DEA’s policy change last year, it is interesting to note that generic Vicodin—a mixture of hydrocodone and acetaminophen—ranked as the drug most widely prescribed to Medicare beneficiaries in 2013, according to a recent article in The Wall Street Journal. This illustrates how comfortable many doctors have become reaching for this powerful painkiller for primary care. An analysis of Medicare data found that more than half of the prescriptions came from family practice or internal medicine physicians. About 691,000 providers prescribed Vicodin in 2013 to more than eight million Medicare beneficiaries, according to the Journal.

According to the CDC, overdoses from prescription painkillers have reached epidemic levels in the past decade. A Schedule 3 substance called buprenorphine may be a key part of the solution. Buprenorphine has been on the market in various forms approved by the U.S. Food and Drug Administration for decades. Buprenex® (an injectable formulation of buprenorphine) and Butrans® (buprenorphine transdermal patch) are FDA-approved to treat pain. A new buprenorphine delivery system that uses BEMA® technology is currently awaiting FDA review. The BEMA drug delivery technology consists of a small, bioerodible polymer film for application to the mucosal membranes (inner lining of cheek). BEMA films were designed to rapidly deliver a dose of drug across the mucous membranes for time-sensitive conditions or to facilitate administration of drugs with poor oral (pill) absorption.

Pivotal data from two Phase 3 studies investigating the BEMA buprenorphine product (now named BELBUCA®) were presented earlier this year by Endo Pharmaceuticals, Inc. and BioDelivery Sciences International, Inc. at the American Pain Society’s 34th Annual Scientific Meeting in Palm Springs, CA. The findings showed buprenorphine consistently decreased pain scores compared to placebo in patients with chronic back pain. In both trials, the buccal film format of buprenorphine was effective in reducing pain at every week studied. A total of 971 randomized patients completed both trials, including pain sufferers who either were receiving opioid therapy or were opioid-naïve at the start of the study. A statistically significant percentage of patients using the form of buprenorphine being studied experienced pain reductions of greater than 30 percent compared to placebo.

The Endo/BDSI formulation of buprenorphine is currently under review by the FDA with a PDUFA action date in October 2015, for use in patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

For those patients who need relief from chronic pain, navigating a path to effective treatment can be challenging. Schedule 3 substances such as buprenorphine, when delivered in a buccal format, could offer a promising alternative with lower potential for abuse and addiction compared to Schedule 2 drugs such as OxyContin, Dilaudid and others.

Matthew A. Torrington, M.D. is a family medicine physician in Culver City, CA with a specialty in addiction medicine. He is also a clinical research physician at the University of California, Los Angeles.


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