A new opiate-based painkiller called Hysingla ER, which gained FDA approval late last year, has hit pharmacy shelves and is renewing the debate about the safety of opiate painkillers. The approval came after a year of challenges and lawsuits over a similar drug with states protesting the development of more opiate-based drugs given the challenges in controlling abuse. Manufacturers rebuff those claims saying that the hydrocodone bitartrate formulation offers something new that other opiate-based drugs don’t have. They also point to its anti-abuse properties that are designed to curtail abuse. Still, with the ever-increasing addiction rate for opiates, the question remains do we need yet another drug that can potentially cause more harm than good?
Hysingla ER Benefits
Purdue’s Hysingla ER does offer several advantages over other opiate formulations. Primarily, it is the first hydrocodone drug that contains abuse-deterrent properties. These additives prevent the drugs from being watered down so that abusers can inject them hypodermically. Instead, when water is added, Hysingla ER turns into a thick gel-like substance. The pills are also very difficult to crush, which is designed to stop those who abuse it by snorting it or chewing it to obtain an immediate high. Another unique quality of Hysingla ER is that it contains no acetaminophen, no non-steroidal anti-inflammatory drugs (NSAID) or other analgesic pain relievers. It is also an extended release formulation, meaning that the active ingredients are released into the blood stream over the course of the day rather than all at once. This greatly reduces the chance of accidental overdose due to increased pain recurrence.
Although the addition of abuse-deterrent properties is a step forward in painkiller manufacturing, it does not stop opiate drug abuse. Instead, it simply reduces it by making it harder. In addition, the extended-release properties of Hysingla ER make it a powerful drug that should only be taken once per day as prescribed. Therefore, patients who abuse the drug, either intentionally or unintentionally, can end up with large doses of opiates in their system for a longer period of time.
The Opiate Manufacturing Debate Rages On
Although advances have been made with regards to reducing opiate abuse, the numbers are still staggering. Given the known addictive qualities of opiate painkillers, it is questionable whether additional ones need to be introduced to the marketplace. Many physicians argue that instead, manufactures should focus on formulating drugs to replace existing ones that are unsafe. For example, some states have strongly pushed to require all opiate-based drugs to include tampering properties. Yet, new drugs, such as Zohydro ER, have gained recent FDA approval without having these properties.
Hydrocodone painkillers are one of the most highly prescribed opioids in the U.S., with over 120 million prescriptions written in 2014. Unfortunately, according to federal surveys, hydrocodone is also the most commonly abused opioid. While the FDA conducts pre-approval studies to measure a potential drug’s pain relief effectiveness, no studies are preformed on the addictive qualities or potential for abuse. While states and local governments are on board with increasing regulations and decreasing the number of new opiate drugs, the FDA continues to approve new ones that could lead to a setback in the fight against opiate addiction and deaths.