Market Overview

DEA Publishes Final Rule on Hydrocodone Rescheduling, Met with Mixed Opinions


A new U.S. Drug Enforcement Administration rule has rescheduled narcotic painkillers from Substance III to Substance II in a move to stop the rise in opioid abuse in the U.S., several reports stated. 

According to the latest data available from the Centers for Disease Control and Prevention, 16651 deaths were linked to prescription opioids in the U.S.

Up-scheduling will place opioid analgesics higher in the regulated drugs category, which will restrict patients to receiving the drugs for a maximum of 90 days without having to obtain a new prescription. The pills can be refilled up to five times from a prescription that is valid up to 180 days.

"Today's action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available," DEA Administrator Michele Leonhart was quoted as saying by The Wall Street Journal in late August, when the rule was finally published on the Federal Register website. The rule will take effect on October 6.

The FDA Advisory Committee in January 2012 voted 19 to 10 in favor of the hydrcodone upscheduling, according to the blog of law firm Hyman, Phelps & McNamara.

According to MedScape, the DEA released its formal proposal in February for public comment until April. 52 percent of the 573 comments it received were in favor of the drug rescheduling, while some 41 percent voted against the rule, and another 7 percent voted neutral.

Prior to the ruling, industry representatives argued that the rescheduling of hydrocodone would bring expensive costs on drug merchants and patients, “with no discernible reduction on abuse and diversion,” according to the blog post.

It added that patient representatives are against having patients see their physicians more frequently (i.e. once a month) as prescriptions are easily refilled. As a result, physicians could raise prescription volume, which could lead to abuse due to increase availability of pills on hand.

In another report, pain experts noted that tighter restrictions on patients’ access to drugs to turn to the black market for pain relief.

“To think that rescheduling of hydrocodone is going to have a huge positive in the war on drugs is really a big mistake,” Dr. Jefferey Fudin, pharmacist and pain patient advocate, told National Pain Report. The news web site is backed by The National Pain Foundation.

“I think from a black market standpoint overall, you may see heroin use go up. We’ve already seen because of PDMPs (prescription drug monitoring programs), as we’re tracking drugs more closely, that heroin use went up because people that are trying to get these drugs can’t get it as readily as they could before. So if the same holds true and they can’t get hydrocodone, it’s one less thing that they can get their hands on. They may go to the street to get heroin because it’s relatively cheap,” Fudin explained.

Some drug makers themselves, however, approve of the DEA’s decision to move forward with the ruling. Mallinckrodt, a major manufacturer of hydrocodone combination drugs, noted in the Journal report that the DEA’s decision supports a “comprehensive approach” to bringing down opioid abuse in the country.

 “We do not believe the rescheduling of these hydrocodone combination products is likely to have a significant impact on our business,” Lynn Phillips, a Mallinckrodt spokeswoman, told the Journal.

Opioid addiction is a growing epidemic in the United States, but it can be successfully treatable with medications like naltrexone. Naltrexone is a type of antagonistdrug that prevents opioids from binding into the brain’s receptors, preventing the addict from experiencing euphoria during drug intake. Its effects last for several months.

The Start Fresh Program, which was developed by BioCorRx, Inc. (OTCQB: BICX), is a two-tiered rehabilitation program that uses naltrexone. The first phase of the program involves an outpatient medical procedure to embed a specially formulated, biodegradable naltrexone implant under the skin and fatty tissue in the lower abdominal area.

The second tier of the program involves a private, one-on-one coaching program to address the specific needs of the individual and to helphim or her plan for a life free from substance abuse.

For more information on BioCorRx, Inc.’s Start Fresh Program, you may reach the company’s headquarters via phone: 714-462-4880, or by visiting

The preceding article is from one of our external contributors. It does not represent the opinion of Benzinga and has not been edited.


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