Buprenorphine (Photo : The Drug Classroom/YouTube)
The extent of the opioid epidemic in the U.S. is so pervasive that the Substance Abuse and Mental Health Services Administration’s (SAMHSA) National Survey on Drug Use and Health estimated that around 23.5 million Americans, aged 12 or older, are addicted to drugs and alcohol.
In 2007, the American public spent nearly $200 billion in in healthcare, criminal justice, legal, and lost workplace production/participation costs due to drug addiction, according to data provided by the Office of National Drug Control Policy (ONDCP). It is estimated that the annual cost to the U.S. healthcare system from illegal drugs amounts to $11 billion per year, and the economic cost is pegged at $193 billion annually. While alcohol abuse costs taxpayers an estimated $223 billion in health care costs and lost productivity.
Combined, alcohol and illegal drug abuse is now a huge burden to the U.S. economy, estimated to total at least 17.1 percent of the annual U.S. federal budget. The direct health care expenses for alcohol, tobacco, illegal, and prescription drug is estimated at $137 billion per year, while total economic cost, including crime and lost productivity could reach more than $600 billion annually.
“Drug and alcohol abuse is obviously a serious problem in the United States,” said Brady Granier, President, CEO and director of BioCorRx, Inc. (BICX). “It’s not just the healthcare system that is impacted. The problem needs to solved, but in order to do that, we need more prevention initiatives and better treatment options for individuals wanting treatment. Perhaps the biggest issue in regards to treatment, is getting those that actually need help into treatment. With only about 10 percent of those with a problem getting treatment, more needs to be done to encourage the other 90 percent to get help. With the growth of medication-assisted treatment (MAT) and outpatient programs, there are more options available to those that want help. Many of these programs can be done discreetly which we hope will encourage more to seek help. Many experts feel that the reason more aren’t seeking help is because of the negative stigma that traditionally comes with addiction. That is probably one of the biggest hurdles in the industry that can hopefully change with time.”
MAT is the combination of medications and counseling to treat alcohol and opioid addictions. The most common medications used in MAT are methadone, buprenorphine, and naltrexone. Suboxone is a commonly known brand name in the buprenorphine space. Revia and Vivitrol are brand names for certain naltrexone products. Unfortunately, some anti-opioid abuse medications available in the market are suspected of causing more health complications and sometimes deaths, especially if prescribed by unscrupulous doctors.
Is There a Dark Side with Buprenorphine?
British multinational consumer goods company Reckitt Benckiser Group plc (RB), with about $55.22 billion in capitalization, has developed buprenorphine in the 1960s as a treatment for moderate pain. However, in 2000, Reckitt Benckiser was allowed to sell the drug to treat patients with opiate dependency in combination with naloxone.
In 2002, after a long and laborious fight, Reckitt Benckiser convinced Congress to give it a seven-year “orphan drug” patent for Suboxone, the brand name for buprenorphine, making the drug a first-line treatment for opioid abuse. Federal funds were poured into the development of Suboxone and it was marketed as a safe anti-opioid dependency drug. For the effort, Reckitt Benckiser earned $1.55 billion in the U.S. alone on Suboxone sales in 2012.
Developed as a long-term treatment for opioid abuse and as a painkiller, buprenorphine is an opioid itself that can trigger dependency and even euphoria similar to the effects of prescription drugs like acetaminophen/oxycodone (Percocet) or oxycodone (OxyContin). However, SAMHSA said that the effect of buprenorphine and the risk of addiction and abuse are less likely and even less deadly.
Since its sales began in 2002, Suboxone has been faced with controversies as several critics of the drug describe buprenorphine as having evolved both as medication and recreational drug. The drug, while reporting some success in the fight against opioid abuse, has also opened the doors for unscrupulous individuals and has even resulted in deaths.
In an article written by the New York Times, Shawn Verrill of South Berwick, Maine, narrated in an interview at a federal prison in Otisville, New York how her then 20-year-old friend Miles Malone died in 2010 after taking Suboxone.
“I didn’t know you could overdose on Suboxone,” Verrill said. “We were just a bunch of friends getting high and hanging out, doing what 20-year-olds do. Then we went to sleep, and Miles never woke up.”
Dr. Robert Newman, a leading advocate of methadone treatment, commented about buprenorphine in the same article, “The safety factor should not be oversold. It is diverted and sold on the black market. It is misused, and it does lead to medically adverse consequences, including death. It is associated with a large number of deaths.”
Reckitt Benckiser, the maker of Suboxone, is also at the center of a massive antitrust lawsuit that was filed in a federal court in Philadelphia in September 2016, accusing the company of “destroying the drug” in a bid to maintain its chokehold on the market.
The 92-page complaint identified 35 states and the District of Columbia as plaintiffs, questioning Reckitt Benckiser move to spinoff Indivior, and a third company called MonoSol RX, by allegedly using a series of “deceptive and unconscionable” practices to profit from drug addiction treatment.
The charge sheet accused the company of “product hopping” by making minor tweaks on a product, without actual development to apply for a new patent with the aim of keeping its market share on said product, particularly Suboxone.
Naltrexone Gaining Popularity as Opioid Antagonist; Inhibitor
Approved by the Food and Drug Administration for opioid addiction in 1984, naltrexone is a pure opioid antagonist. Clinical tests have shown that naltrexone is effective in reducing or completely reversing and blocking the effects of intravenously administered opioids.
Indeed, law enforcement agencies, including first medical responders, have been looking at the potential of naltrexone as an anti-drug and alcohol abuse treatment. Prison systems across the U.S. have started opioid abuse rehabilitation treatment programs using injectable naltrexone as the preferred treatment.
The West Virginia Division of Corrections announced in late 2016 that it has started offering Vivitrol, a monthly injection of naltrexone, to its soon-to-be-released inmates to prevent relapse to opioids once they are released and back in their environment.
Vivitrol is manufactured by Alkermes PLC, (ALKS), an $8-billion pharmaceutical company which sells the drug at $1,300 per shot. Naltrexone is being described as a wonder drug by some in the treatment of opioid addiction, although critics are skeptical about the effectiveness of the drug.
Another pharmaceutical firm Barr Laboratories, a subsidiary of Teva Pharmaceuticals (TEVA), is also selling naltrexone under the brand name Revia.
Granier from BioCorRx, which is developing its own injectable naltrexone called BICX101, said, “We believe that sustained release naltrexone products such as BICX101 will become the gold standard of long term addiction treatment and relapse prevention, especially once more efficient detox protocols and products are standardized such as the IHS BRIDGE device.”
BICX101 is a new injectable naltrexone currently in development from BioCorRx (BICX). The company plans to seek FDA approval via 505(b)(2) application.
