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With the drug addiction treatment market being about $35 billion a year in the U.S. alone, it is easy to understand why the industry is rapidly becoming a popular space.
Big pharmaceutical companies, like Insys Therapeutics Inc. (INSY), Pfizer Inc. (PFE), Amphastar Pharmaceuticals Inc. (AMPH), Mylan N.V. (MYL), Opiant Technologies Inc. (OPNT), Adapt Pharma Ltd., Kaleo Pharmaceuticals, Alkermes (ALKS), and newcomer BioCorRx, Inc. (BICX) are all jockeying for position to get a bigger slice of the market.
Brady Granier, president, CEO and director of BioCorRx, commented, “This epidemic is showing no signs of slowing and more options are needed for treatment and prevention. It is a very large market that is showing some signs of consolidation within the treatment center space. We are seeing an increase in traditional programs making a shift towards medication-assisted treatment (MAT). One of the big three medications used in MAT is naltrexone. Many of these traditional programs are beginning to use or endorse the use of naltrexone because of its non-addictive nature. It’s an effective medication that should be getting as much attention as that of naloxone.”
Anti-Drug Addiction Market is a Rapidly Growing Industry
The Food and Drug Administration (FDA) approved Adapt Pharma Ltd.’s NARCAN Nasal Spray formulation in November 2015. Adapt Pharma has signed a licensing deal with Opiant Pharmaceuticals’ (formerly Lightlake Therapeutics) to use its intranasal opioid antagonist platform technology in the development of the NARCAN Nasal Spray. The deal could earn Opiant up to $55 million in milestone payments aside from double-digit percentage royalties from Adapt on NARCAN Nasal Spray sales.
However, Adapt is not the only pharmaceutical company selling NARCAN as an anti-overdose medication. Pfizer’s subsidiary, Hospira, and Amphastar Pharmaceuticals are pioneers in injectable naloxone. These two companies are, in fact, being blamed for the sudden rise in the price of naloxone.
In its latest filing, Amphastar said that naloxone accounted for $38.6 million of the firm’s $251.5 million revenue in 2015, and expects the numbers to rise further as the price of the medication increases. It added that it is currently working on the development of a naloxone nasal spray.
For its part, Kaleo Pharmaceuticals is marketing a naloxone auto-injector under the Evzio brand name at about $700-$800 per dose. Biotech giant, Mylan, has started selling a naloxone injectable after receiving FDA approval in 2014. Troubled company INSYS Therapeutics is hoping to revive its stock price after getting a naloxone candidate assigned by the FDA as fast-track eligible.
Alkermes, an $8.3-billion pharmaceutical company, is offering an injectable naltrexone which is used to block the effects of opioids, at a cost of $1,300 per shot under its Vivitrol brand name. Vivitrol sales reached $55.8 million in the first three quarters of 2016. Alkermes is projecting that the sales of Vivitrol could reach a billion-dollar status in the near future and is looking to reach between $700 million and $800 million sales by 2018.
In January, BioCorRx announced it would be working with Innovative Science Solutions to assist the company with regulatory matters for the release of its naltrexone injectable product, BICX101, and one or more other naltrexone formularies. BICX101 is currently in preclinical development under BioCorRx’s pharmaceutical subsidiary, in partnership with TheraKine.
BioCorRx’s partnership with Innovative Science Solutions makes its hope of an FDA approval for BICX101 more likely.
Naloxone vs Naltrexone
In the fight against drug addiction, what is the difference between naloxone and naltrexone?
The FDA approved naloxone as a generic drug in 1971. It is often used by first responders and police officers to reverse opioid overdose in an acute situation. Naloxone is being sold as an over-the-counter drug and is sold without a prescription in some states. It can save lives once administered when someone is suspected of overdosing, but it only lasts a short time and the person then needs to be rushed to the hospital for observation. It’s used for overdose and not for long-term addiction treatment.
It’s counterpart, naltrexone, is mainly used to reduce cravings and for relapse prevention. If one has therapeutic levels of naltrexone in their system, they can be protected from overdosing as the naltrexone blocks the opioids from binding with the receptors in the brain. BioCorRx is in early stages of development for a new injectable naltrexone called BICX101.
Granier explained, “We believe that any form of sustained release naltrexone is of great benefit in preventing relapse and overdose and the more options we have, the better. BICX101 is being developed with the goal of improving patient compliance by reducing dose volume, needle size, and many other factors which can make compliance with other products more challenging.”
